VersiTomic Low Profile 2.4mm Guide Pin, Sterile, Trocar
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- VersiTomic Low Profile 2.4mm Guide Pin, Sterile, Trocar EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Cruciate Ligament Instruments EUDAMED
- Model / Reference
- Cruciate Ligament Instruments EUDAMED162100stRR2 EUDAMED234-111-024 FDA UDI
Identifiers
- Catalog Number
- 162100stRR2 FDA UDI
- Primary DI / UDI-DI
- 10818674029053 EUDAMEDFDA UDI
- Basic UDI-DI
- 81012846CRUCIAETLIGINSV3 EUDAMED
- Direct Marketing DI
- 10818674029053 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Joint prosthesis implantation kit, single-use
VersiTomic Low Profile 2.4mm Guide Pin, Sterile, Trocar by T.A.G. Medical products corporation LTD. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 81012846CRUCIAETLIGINSV3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- T.A.G. Medical products corporation LTD.
- EUDAMED SRN
- IL-MF-000029151
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (2)
- EUDAMED c9252584-c982-4642-9ca9-147e8dda6378 61 fields · synced Jun 17, 2026
- FDA UDI be467d81-9cbb-485c-ab93-a63978f43583 33 fields · synced May 29, 2026