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Intervascular InterGard Silver Vascular Prostheses - HSA Registration DE0012089

Access comprehensive regulatory information for Intervascular InterGard Silver Vascular Prostheses in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0012089 and owned by Intervascular SAS. The device was registered on January 04, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0012089
Intervascular InterGard Silver Vascular Prostheses
HSA Registration Number: DE0012089
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Product Description

InterGard Silver antimicrobial collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurismal and occlusive disease of the thoracic aorta (except InterGard Silver antimicrobial Knitted grafts), abdominal aorta (except InterGard Silver antimicrobial Knitted UltraThin grafts), visceral arteries, and peripheral arteries. Due to the low porosity, these products are recommended for use in patients requiring heparinization prior to or during surgery. The coating of silver is designed to inhibit the microbial colonization on the device and within tissue immediately proximate to the device in the acute post operative phase.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00111
HS Code
90213900
Registration Information
Registration Number
DE0012089
Registration Date
January 04, 2013
Change Notification Approval Date
February 21, 2025
Retention Due Date
January 03, 2026
Product Owner
Short Name
Intervascular SAS
Address
ZI Athélia 1, 270 voie Ariane, 13600 La Ciotat, FRANCE
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, CyberHub Building, #06-02, SINGAPORE 339914 20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Model Information
Model Name(s)
InterGard Silver Knitted Straight D 6 mm x L 20 cm InterGard Silver Knitted Straight D 6 mm x L 40 cm InterGard Silver Knitted Straight D 6 mm x L 70 cm InterGard Silver Knitted Radially Supported D 6 mm x Supported L 20 cm x Distal L 35 cm x Proximal L15 cm x Total L 70 cm InterGard Silver Knitted Radially Supported D 6 mm x Supported L 30 cm x Distal L 25 cm x Proximal L15 cm x Total L 70 cm InterGard Silver Knitted Radially Supported D 6 mm x Supported L 45 cm x Distal L 25 cm x Proximal L15 cm x Total L 85 cm InterGard Silver Knitted Straight D 7 mm x L 40 cm InterGard Silver Knitted Straight D 7 mm x L 70 cm InterGard Silver Knitted Straight D 8 mm x L 20 cm InterGard Silver Knitted Straight D 8 mm x L 40 cm InterGard Silver Knitted Straight D 8 mm x L 70 cm InterGard Silver Knitted Radially Supported D 8 mm x Supported L 15 cm x Distal L 12,5 cm x Proximal L12,5 cm x Total L 40 cm InterGard Silver Knitted Radially Supported D 8 mm x Supported L 15 cm x Distal L 40 cm x Proximal L15 cm x Total L 70 cm InterGard Silver Knitted Radially Supported D 8 mm x Supported L 20 cm x Distal L 35 cm x Proximal L15 cm x Total L 70 cm InterGard Silver Knitted Radially Supported D 8 mm x Supported L 30 cm x Distal L 25 cm x Proximal L15 cm x Total L 70 cm InterGard Silver Knitted Radially Supported D 8 mm x Supported L 45 cm x Distal L 25 cm x Proximal L15 cm x Total L 85 cm InterGard Silver Knitted Radially Supported D 8 mm x Supported L 60 cm x Distal L 25 cm x Proximal L15 cm x Total L 100 cm InterGard Silver Knitted Straight D 10 mm x L 40 cm InterGard Silver Knitted Straight D 10 mm x L 70 cm InterGard Silver Knitted Radially Supported D 10 mm x Supported L 10 cm x Distal L 15 cm x Proximal L15 cm x Total L 40 cm InterGard Silver Knitted Straight D 12 mm x L 20 cm InterGard Silver Knitted Straight D 12 mm x L 40 cm InterGard Silver Knitted Straight D 14 mm x L 20 cm InterGard Silver Knitted Straight D 14 mm x L 40 cm InterGard Silver Knitted Straight D 16 mm x L 20 cm InterGard Silver Knitted Straight D 16 mm x L 40 cm InterGard Silver Knitted Straight D 18 mm x L 20 cm InterGard Silver Knitted Straight D 18 mm x L 40 cm InterGard Silver Knitted Straight D 20 mm x L 20 cm InterGard Silver Knitted Straight D 20 mm x L 40 cm InterGard Silver Knitted Straight D 22 mm x L 20 cm InterGard Silver Knitted Straight D 22 mm x L 40 cm InterGard Silver Knitted Straight D 24 mm x L 20 cm InterGard Silver Knitted Straight D 24 mm x L 40 cm InterGard Silver Knitted Bifurcated D 12 x 6 mm - L 50 cm InterGard Silver Knitted Bifurcated D 14 x 7 mm - L 50 cm InterGard Silver Knitted Bifurcated D 16 x 8 mm - L 50 cm InterGard Silver Knitted Bifurcated D 18 x 9 mm - L 50 cm InterGard Silver Knitted Bifurcated D 20 x 10 mm - L 50 cm InterGard Silver Knitted Bifurcated D 22 x 11 mm - L 50 cm InterGard Silver Knitted Bifurcated D 24 x 12 mm - L 50 cm InterGard Silver Knitted Axillo-bifemoral D 8 x 6 mm - Supported L 35 x 20 cm - Total L 85 x 55 cm InterGard Silver Knitted Axillo-bifemoral D 8 x 8 mm - Supported L 45 x 20 cm - Total L 85 x 55 cm InterGard Silver Knitted Axillo-bifemoral D 8 x 8 mm - Supported L 45 x 30 cm - Total L 85 x 55 cm InterGard Silver Knitted Axillo-bifemoral D 8 x 8 mm - Supported L 60 x 30 cm - Total L100 x 55 cm InterGard Silver Knitted Axillo-bifemoral D 8 x 8 mm - Total L 100 x 60 cm InterGard Silver Woven Straight D 8 mm x L30 cm InterGard Silver Woven Straight D 10 mm x L30 cm InterGard Silver Woven Straight D 12 mm x L15 cm InterGard Silver Woven Straight D 12 mm x L30 cm InterGard Silver Woven Straight D 14 mm x L15 cm InterGard Silver Woven Straight D 14 mm x L30 cm InterGard Silver Woven Straight D 16 mm x L15 cm InterGard Silver Woven Straight D 16 mm x L30 cm InterGard Silver Woven Straight D 18 mm x L15 cm InterGard Silver Woven Straight D 18 mm x L30 cm InterGard Silver Woven Straight D 20 mm x L15 cm InterGard Silver Woven Straight D 20 mm x L30 cm InterGard Silver Woven Straight D 22 mm x L15 cm InterGard Silver Woven Straight D 22 mm x L30 cm InterGard Silver Woven Straight D 24 mm x L15 cm InterGard Silver Woven Straight D 24 mm x L30 cm InterGard Silver Woven Straight D 26 mm x L15 cm InterGard Silver Woven Straight D 26 mm x L30 cm InterGard Silver Woven Straight D 28 mm x L15 cm InterGard Silver Woven Straight D 28 mm x L30 cm InterGard Silver Woven Straight D 30 mm x L15 cm InterGard Silver Woven Straight D 30 mm x L30 cm InterGard Silver Woven Straight D 32 mm x L15 cm InterGard Silver Woven Straight D 32 mm x L30 cm InterGard Silver Woven Bifurcated D 14 x 7 mm x L 50 cm InterGard Silver Woven Bifurcated D 16 x 8 mm x L 50 cm InterGard Silver Woven Bifurcated D 18 x 9 mm x L 50 cm InterGard Silver Woven Bifurcated D 20 x 10 mm x L 50 cm InterGard Silver Woven Bifurcated D 22 x 11 mm x L 50 cm InterGard Silver Woven Bifurcated D 24 x 12 mm x L 50 cm
Model Identifier(s)
IGK0006-20S IGK0006-40S IGK0006-70S IGK0006RS20S IGK0006RS30S IGK0006RS45S IGK0007-40S IGK0007-70S IGK0008-20S IGK0008-40S IGK0008-70S IGK0008RS15-40S IGK0008RS15S IGK0008RS20S IGK0008RS30S IGK0008RS45S IGK0008RS60S IGK0010-40S IGK0010-70S IGK0010RS10-40S IGK0012-20S IGK0012-40S IGK0014-20S IGK0014-40S IGK0016-20S IGK0016-40S IGK0018-20S IGK0018-40S IGK0020-20S IGK0020-40S IGK0022-20S IGK0022-40S IGK0024-20S IGK0024-40S IGK1206S IGK1407S IGK1608S IGK1809S IGK2010S IGK2211S IGK2412S IGKAX080606RS35/20S IGKAX0808RS45/20S IGKAX0808RS45/30S IGKAX0808RS60/30S IGKAX0808S IGW0008-30S IGW0010-30S IGW0012-15S IGW0012-30S IGW0014-15S IGW0014-30S IGW0016-15S IGW0016-30S IGW0018-15S IGW0018-30S IGW0020-15S IGW0020-30S IGW0022-15S IGW0022-30S IGW0024-15S IGW0024-30S IGW0026-15S IGW0026-30S IGW0028-15S IGW0028-30S IGW0030-15S IGW0030-30S IGW0032-15S IGW0032-30S IGW1407S IGW1608S IGW1809S IGW2010S IGW2211S IGW2412S