Identity
- Trade Name
- SE EUDAMEDFDA UDI
- Generic Name
- Ligament reconstruction instrument set, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Reusable Surgical Instrument, Graft Preparation EUDAMEDSE GRAFT TENSIONER SUTURE SEPARATORS FDA UDI
- Model / Reference
- C9053 EUDAMEDFDA UDI
- Description
- SE GRAFT TENSIONER SUTURE SEPARATORS FDA UDI
Identifiers
- Catalog Number
- C9053 FDA UDI
- Primary DI / UDI-DI
- 10845854034521 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854034521 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Ligament reconstruction instrument set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Se by Conmed Corporation — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10845854034521 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (3)
- EUDAMED 518f87a2-fd5d-42cb-ad1f-b5341e7c2afc 61 fields · synced Jun 18, 2026
- FDA UDI 95f2cc8d-0041-4c07-a8fa-b211ccaba09c 36 fields · synced May 29, 2026
- EUDAMED 23fdd349-7402-49d4-8342-e916c25051e4 61 fields · synced Jun 18, 2026