Identity
- Trade Name
- Button Holder EUDAMEDFDA UDI
- Generic Name
- Tendon/ligament graft preparation station post FDA UDI
- Device Name
- Ligament Tensioner - Non-measuring EUDAMEDIntended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction FDA UDI
- Model / Reference
- 72205273 EUDAMEDFDA UDI
- Description
- Intended to be used for the preparation and pre-tensioning of single tendon grafts for ligament reconstruction FDA UDI
Identifiers
- Catalog Number
- 72205273 FDA UDI
- Primary DI / UDI-DI
- 09421028111942 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN00172A EUDAMED
- Direct Marketing DI
- 09421028111942 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091106 INSTRUMENTS FOR THE PREPARATION OF TISSUE IMPLANTS IN ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY, REUSABLE EUDAMED
- GMDN Term
- Tendon/ligament graft preparation station post 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Button Holder by Enztec Limited — 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 | 942102811GMN00172A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enztec Limited
- EUDAMED SRN
- NZ-MF-000002264
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED b9db19f0-fe00-4cd1-831d-817421bfba1b 61 fields · synced Jul 9, 2026
- FDA UDI 83df6f4f-dd27-44ee-ad2f-b4b2e2f3ce66 34 fields · synced May 30, 2026