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ABLE Advanced Anterior Approach Set with Case
EUDAMEDFDA UDIClass I (EU MDR)
Ref 6161-01
Identity
- Trade Name
- ABLE Advanced Anterior Approach Set with Case EUDAMEDInnomed, Inc. FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Retractor EUDAMEDABLE Advanced Anterior Approach Set with Case FDA UDI
- Model / Reference
- 6161-01 EUDAMEDFDA UDI
- Description
- ABLE Advanced Anterior Approach Set with Case FDA UDI
Identifiers
- Catalog Number
- 6161-01 FDA UDI
- Primary DI / UDI-DI
- 00840277114198 EUDAMEDFDA UDI
- Basic UDI-DI
- 8402771INNORETRACT016A EUDAMED
- Direct Marketing DI
- 00840277114198 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
ABLE Advanced Anterior Approach Set with Case 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 9135805e-2f34-4c35-af7e-2bc904eb802b 61 fields · synced Jun 18, 2026
- FDA UDI 0df0a9a7-d0c2-41e7-8cf4-b5da1d0d8472 34 fields · synced May 30, 2026