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Ethicon Endo-Surgery Generator G11 System - HSA Registration DE0009167

Access comprehensive regulatory information for Ethicon Endo-Surgery Generator G11 System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0009167 and owned by Ethicon Endo-Surgery, LLC. The device was registered on May 17, 2012.

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 C
DE0009167
Ethicon Endo-Surgery Generator G11 System
HSA Registration Number: DE0009167
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Product Description

The Generator G11 provides radiofrequency power to drive EnSeal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0009167
Registration Date
May 17, 2012
Change Notification Approval Date
March 07, 2025
Retention Due Date
May 16, 2025
Product Owner
Short Name
Ethicon Endo-Surgery, LLC
Address
475 Calle C, Guaynabo, Puerto Rico 00969, UNITED STATES
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
Generator G11 HARMONICยฎ 1100 Shears, 20cm length HARMONICยฎ 1100 Shears, 36cm length Harmonic FOCUS Long Shears + Adaptive Tissue Technology HARMONIC ACEยฎ 5 mm Diameter Shears 23 cm Length + Adaptive Tissue HARMONIC ACEยฎ 5 mm Diameter Shears 36 cm Length + Adaptive Tissue HARMONICโ„ข 700 Shears, 23cm Shaft Length HARMONICโ„ข 700 Shears, 36cm Shaft Length HARMONICโ„ข 700 Shears, 45cm Shaft Length Harmonic FOCUSโ„ข Shears + Adaptive Tissue Technology HARMONIC ACE+7 Shears With Advanced Hemostasis HARMONIC ACE+7 Laparoscopic Shears With Advanced Hemostasis HARMONIC ACE+7 Laparoscopic Shears With Advanced Hemostasis HARMONIC HD 1000i Shears, 20 cm Length HARMONIC HD 1000i Shears, 36 cm Length HARMONIC OSTEOVUE Spine Soft Tissue Dissector
Model Identifier(s)
GEN11 HAR1120 HAR1136 HAR17F HAR23 HAR36 HAR723 HAR736 HAR745 HAR9F HARH23 HARH36 HARH45 HARHD20 HARHD36 HARSB