Identity
- Trade Name
- CTS RELIEF KIT EUDAMEDFDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Surgical Procedure Kit, CTS EUDAMEDCTS RELIEF KIT, CARPAL TUNNEL SYNDROME RELIEF KIT FDA UDI
- Model / Reference
- 9971 EUDAMEDFDA UDI
- Description
- CTS RELIEF KIT, CARPAL TUNNEL SYNDROME RELIEF KIT FDA UDI
Identifiers
- Catalog Number
- 9971 FDA UDI
- Primary DI / UDI-DI
- 10845854026397 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854026397 EUDAMED
- FDA Product Code
- MDM FDA UDI
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
- GMDN Term
- Arthroscopic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cts Relief Kit by Conmed Corporation — Class IIa — 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-10845854026397 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 90350979-acb7-4ff4-a689-8891b1f8915d 61 fields · synced Jun 17, 2026
- FDA UDI 23849bd0-19a3-434e-a0f5-d51acfa6fc64 36 fields · synced May 30, 2026
- EUDAMED 3636335f-d5fb-42c9-86fa-7382bd7d33f7 61 fields · synced Jun 11, 2026