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Calcaneal Distractor Small Outspread Arms Thumbscrew
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4215-SB
Identity
- Trade Name
- Calcaneal Distractor Small Outspread Arms Thumbscrew EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Orthopaedic surgical distractor, external FDA UDI
- Device Name
- Retractor EUDAMEDCalcaneal Distractor Small Outspread Arms Thumbscrew FDA UDI
- Model / Reference
- 4215-SB EUDAMEDFDA UDI
- Description
- Calcaneal Distractor Small Outspread Arms Thumbscrew FDA UDI
Identifiers
- Catalog Number
- 4215-SB FDA UDI
- Primary DI / UDI-DI
- 00840277107763 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277107763 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical distractor, external FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Calcaneal Distractor Small Outspread Arms Thumbscrew by Innomed, 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 | 8402771INNORETRACT016A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innomed, Inc.
- EUDAMED SRN
- US-MF-000014761
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED f9644de2-ea09-4954-b130-9c3e21f2bfff 61 fields · synced Sep 17, 2026
- FDA UDI 5b91a19e-0799-483c-b604-5c843d95f50e 34 fields · synced May 30, 2026