Identity
- Trade Name
- Ratchet EUDAMEDNeoss Implant System FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Torque Instrument EUDAMEDRatchet FDA UDI
- Model / Reference
- 51121 EUDAMEDFDA UDI
- Description
- Ratchet FDA UDI
Identifiers
- Catalog Number
- 51121 FDA UDI
- Primary DI / UDI-DI
- 05060440332531 EUDAMEDFDA UDI
- Basic UDI-DI
- 506044033N0047NB EUDAMED
- Direct Marketing DI
- 05060440332531 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Ratchet by Neoss AB — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506044033N0047NB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neoss AB
- EUDAMED SRN
- SE-MF-000022321
Sources (2)
- EUDAMED 7dbc35e5-d144-4ff0-9422-67aac5e24ccd 61 fields · synced Jul 20, 2026
- FDA UDI 917df4b9-1acb-4197-bf8d-0550e34e060a 35 fields · synced May 30, 2026