Identity
- Trade Name
- OMEGA EUDAMEDFDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- OMEGA 3 INSTRUMENTS - HANDLES AND ADAPTORS - CLASS I - REUSABLE - NON STERILE EUDAMEDOne-Step Insertion Wrench FDA UDI
- Model / Reference
- 704002 EUDAMEDFDA UDI08858251002603SN EUDAMED
- Description
- One-Step Insertion Wrench FDA UDI
Identifiers
- Catalog Number
- 704002 FDA UDI
- Primary DI / UDI-DI
- 07613153054412 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251002603SN EUDAMED
- Direct Marketing DI
- 07613153054412 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- P091280 OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical torque wrench, 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: Surgical torque wrench, reusable
Omega by Stryker Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical torque wrench, reusable.
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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 81c59a4f-1710-4e50-9382-92bead4fe7c9 34 fields · synced Oct 7, 2026
- EUDAMED af9745bc-da52-43e4-bf49-b1264e466c28 61 fields · synced Oct 7, 2026