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Ankle Distraction Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref EKM-AD14407
by Ekcomed Inc.
Identity
- Trade Name
- Ankle Distraction Kit EUDAMEDEKCOMED FDA UDI
- Generic Name
- Limb/torso/head restraint, single-use FDA UDI
- Device Name
- Positioning Products EUDAMEDAnkle Distraction Kit FDA UDI
- Model / Reference
- EKM-AD14407 EUDAMEDFDA UDI
- Description
- Ankle Distraction Kit FDA UDI
Identifiers
- Catalog Number
- EKM-AD14407 FDA UDI
- Primary DI / UDI-DI
- 00850000965102 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850000965positionYS EUDAMED
- Direct Marketing DI
- 00850000965102 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
Ankle Distraction 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 5b4d6985-504a-4cc4-8194-fd0683e14ceb 61 fields · synced Jun 20, 2026
- FDA UDI 914bb95d-9e0f-4185-a3ea-362b15f6ca17 35 fields · synced May 30, 2026