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PCL BackStopper
EUDAMEDFDA UDIClass I (EU MDR)
Ref tg20128stModel Cruciate Ligament Reusable Instruments
Identity
- Trade Name
- PCL BackStopper EUDAMEDFDA UDI
- Generic Name
- Ligament reconstruction instrument set, reusable FDA UDI
- Device Name
- Pin Puller EUDAMED
- Model / Reference
- Cruciate Ligament Reusable Instruments EUDAMEDtg20128st EUDAMEDE FDA UDI
Identifiers
- Catalog Number
- tg20128st FDA UDI
- Primary DI / UDI-DI
- 10810190016418 EUDAMEDFDA UDI
- Basic UDI-DI
- 81012846CRUCIAETLIGRELC EUDAMED
- Direct Marketing DI
- 10810190016418 EUDAMED
- FDA Product Code
- LXH 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
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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Acetabular orthopaedic reamer
PCL BackStopper 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
European Union Active
CE/MDR
United States Pending data
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 d938d539-561f-4a8f-a407-e078be0af502 61 fields · synced Aug 1, 2026
- FDA UDI 8760ea82-ea8a-4180-ba0f-e12122cddf30 33 fields · synced May 29, 2026