4.5mm Full Thickness Drill
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- 4.5mm Full Thickness Drill EUDAMEDFDA UDI
- Generic Name
- Ligament reconstruction instrument set, reusable FDA UDI
- Device Name
- Pin Puller EUDAMED
- Model / Reference
- Cruciate Ligament Reusable Instruments EUDAMEDtg40045st EUDAMEDE FDA UDI
Identifiers
- Catalog Number
- tg40045st FDA UDI
- Primary DI / UDI-DI
- 10810190016456 EUDAMEDFDA UDI
- Basic UDI-DI
- 81012846CRUCIAETLIGRELC EUDAMED
- Direct Marketing DI
- 10810190016456 EUDAMED
- FDA Product Code
- HWK FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Ligament reconstruction instrument set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Acetabular orthopaedic reamer
4.5mm Full Thickness Drill by T.A.G. Medical products corporation LTD. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 81012846CRUCIAETLIGRELC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 efc58f16-b6c8-4fb2-9dc1-7e91bafcdec0 61 fields · synced Aug 5, 2026
- FDA UDI 8def4e3d-19bd-4f60-9147-ee0729d4abba 33 fields · synced May 30, 2026