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TBC Shoulder Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref EKM-TBC1644
by Ekcomed Inc.
Identity
- Trade Name
- TBC Shoulder Kit EUDAMEDEKCOMED FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Device Name
- Positioning Products EUDAMEDTBC Shoulder Kit FDA UDI
- Model / Reference
- EKM-TBC1644 EUDAMEDFDA UDI
- Description
- TBC Shoulder Kit FDA UDI
Identifiers
- Catalog Number
- EKM-TBC1644 FDA UDI
- Primary DI / UDI-DI
- 00850000965058 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850000965positionYS EUDAMED
- Direct Marketing DI
- 00850000965058 EUDAMED
- FDA Product Code
- KDD FDA UDI
- EMDN Code
- Z12130285 ORTHOPAEDIC TRACTION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Limb/torso/head restraint, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
TBC Shoulder Kit by Ekcomed Inc. — 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 | 0850000965positionYS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ekcomed Inc.
- EUDAMED SRN
- US-MF-000048880
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1d7d954d-41b7-445b-ae2e-63831a086d10 61 fields · synced Jul 23, 2026
- FDA UDI 02ad4aa9-1a80-4bf1-ad94-38a41e1f11d7 35 fields · synced May 30, 2026