Identity
- Trade Name
- Gamma4™ EUDAMEDGAMMA FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- GAMMA 4 INSTRUMENTS - HANDLES AND ADAPTORS - CLASS I - REUSABLE - NON STERILE EUDAMEDRC Guide FDA UDI
- Model / Reference
- 1420-3010 EUDAMEDFDA UDI08858251003281SV EUDAMED
- Description
- RC Guide FDA UDI
Identifiers
- Catalog Number
- 1420-3010 FDA UDI
- Primary DI / UDI-DI
- 07613327591507 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251003281SV EUDAMED
- Direct Marketing DI
- 07613327591507 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant-instrument extension adaptor, reusable
Gamma by Stryker Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
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- ACS® — implantcast GmbH · Class I
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- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (2)
- FDA UDI c7c9bd3f-b466-4aa6-b232-aff858ac7225 34 fields · synced Oct 8, 2026
- EUDAMED 8169eb21-bcf2-497a-8952-7067d05f97e4 61 fields · synced Oct 8, 2026