Identity
- Trade Name
- Arthrex EUDAMEDArthrex® FDA UDI
- Generic Name
- Orthopaedic surgical distractor, internal FDA UDI
- Device Name
- AD-OR Table Traction Frame EUDAMEDANKLE DISTRACTOR FDA UDI
- Model / Reference
- AR-1713-01 EUDAMEDFDA UDI
- Description
- ANKLE DISTRACTOR FDA UDI
Identifiers
- Catalog Number
- AR-1713-01 FDA UDI
- Primary DI / UDI-DI
- 00888867021013 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN1090018X EUDAMED
- FDA Product Code
- HST FDA UDI
- EMDN Code
- Z12130285 ORTHOPAEDIC TRACTION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Orthopaedic surgical distractor, internal FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.5850 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Arthrex by Hill-Rom, 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 | 0615521GMN1090018X | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (2)
- EUDAMED bc6794b3-5e60-4412-bfe9-cc5c2a35973f 61 fields · synced Jul 15, 2026
- FDA UDI 422da1b4-7b77-4582-8e56-1c6170380c68 35 fields · synced May 30, 2026