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Howmedica Osteonics Gray Revision Instruments - HSA Registration DE0506061

Access comprehensive regulatory information for Howmedica Osteonics Gray Revision Instruments in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506061 and owned by Howmedica Osteonics Corp.. The device was registered on August 13, 2021.

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 B
DE0506061
Howmedica Osteonics Gray Revision Instruments
HSA Registration Number: DE0506061
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Product Description

Manual surgical instruments intended for use during hip or knee arthroplasty, or trauma surgeries.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0506061
Registration Date
August 13, 2021
Change Notification Approval Date
February 08, 2024
Retention Due Date
August 12, 2025
Product Owner
Short Name
Howmedica
Address
325 Corporate Drive, Mahwah, NJ 07430, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
GRAY REV. INSTR. SYS. STRAIGHT OSTEOTOME DIA. 6.4MM, LENGTH 120MM GRAY REV. INSTR. SYS. STRAIGHT OSTEOTOME DIA. 6.4MM, LENGTH 210MM GRAY REV. INSTR. SYS. CURVED OSTEOTOME DIA. 6.4MM, LENGTH 120MM GRAY REV. INSTR. SYS. CURVED OSTEOTOME DIA. 6.4MM, LENGTH 210MM GRAY REV. INSTR. SYS. STRAIGHT OSTEOTOME DIA. 12.7MM, LENGTH 120MM GRAY REV. INSTR. SYS. CURVED OSTEOTOME DIA. 12.7MM, LENGTH 120MM GRAY REV. INSTR. SYS. FLEXIBLE OSTEOTOME DIA. 12MM, LENGTH 120MM GRAY REV. INSTR. SYS. FLEXIBLE OSTEOTOME DIA. 6MM, LENGTH 67MM GRAY REV. INSTR. SYS. FLEXIBLE OSTEOTOME DIA. 8MM, LENGTH 80MM GRAY REV. INSTR. SYS. FLEXIBLE OSTEOTOME DIA. 12MM, LENGTH 93MM GRAY REV. INSTR. SYS. ACET. OSTEOTOME STARTER OD 40MM GRAY REV. INSTR. SYS. ACETABULAR CUP OSTEOTOME DIA. 46MM GRAY REV. INSTR. SYS. ACETABULAR CUP OSTEOTOME DIA. 56MM GRAY REV. INSTR. SYS. ACETABULAR CUP OSTEOTOME DIA. 66MM GRAY REV. INSTR. SYS. INVERTED "V" TIP OSTEOTOME DIA 6.4MM, LENGTH 120MM GRAY REV. INSTR. SYS. INVERTED "V" TIP OSTEOTOME DIA 6.4MM, LENGTH 250MM GRAY REV. INSTR. SYS. 1/2 ROUND GOUGE DIA. 6.4MM, LENGTH 250MM GRAY REV. INSTR. SYS. OFFSET GOUGE DIA 6.4MM, LENGTH 180MM GRAY REV. INSTR. SYS HOOK, SIZE 2MM, LENGTH 300MM GRAY REV. INSTR. SYS HOOK, SIZE 4MM, LENGTH 300MM GRAY REV. INSTR. SYS HOOK, SIZE 6MM, LENGTH 250MM GRAY REV. INSTR. SYS HOOK, SIZE 10MM, LENGTH 250MM GRAY REV. INSTR. SYS. HOOK SIZE 1MM, LENGTH 300MM GRAY REV. INSTR. SYS. "T" SPLITTER OSTEOTOME SIZE 10MM, LENGTH 125MM GRAY REV. INSTR. SYS. "T" SPLITTER OSTEOTOME SIZE 8MM, LENGTH 250MM GRAY REV. INSTR. SYS. BLUNT NOSE SPLITTER, OSTEOTOME GRAY REV. INSTR. SYS. ACET. CUP CUTTING TIP OSTEOTOME SIZE 26MM, LENGTH 140MM GRAY REV. INSTR. SYS. ACET. CUP CUTTING TIP OSTEOTOME SIZE 32MM, LENGTH 140MM 3.2MM ๏ฟฝ 254MM GRAY REV INSTR SYS REVISION GRAY DRILL GRAY REV. INSTR. SYS. CANNULATED END MILL DIA 12.7MM, LENGTH 254MM GRAY REV. INSTR. SYS. CANNULATED END MILL DIA 12.7MM, LENGTH 330MM GRAY REV. INSTR. SYS. CANNULATED END MILL DIA. 9.5MM, LENGTH 254MM GRAY REV. INSTR. SYS. CANNULATED END MILL DIA. 9.5MM, LENGTH 330MM GRAY REV. INSTR. SYS. CANNULATED TREPHINE
Model Identifier(s)
6210-0-100 6210-0-200 6210-0-300 6210-0-400 6210-0-500 6210-0-600 6210-0-710 6210-0-720 6210-0-730 6210-0-740 6210-0-810 6210-0-815 6210-0-820 6210-0-825 6210-1-100 6210-1-200 6210-2-100 6210-2-200 6210-3-100 6210-3-200 6210-3-300 6210-3-400 6210-3-450 6210-4-100 6210-4-200 6210-4-300 6210-5-100 6210-5-200 6210-9-020 6210-9-030 6210-9-035 6210-9-040 6210-9-045 6210-9-100