Identity
- Trade Name
- Oxford concise MCL retractor EUDAMEDMCL Retractor FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- ASKORN CLASS IR INSTRUMENTS EUDAMED
- Model / Reference
- 3000-02 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700751500657 EUDAMED03700751500015 FDA UDI
- Basic UDI-DI
- 3700751500005J EUDAMED
- Direct Marketing DI
- 03700751500657 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
- 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hand-held surgical retractor, reusable
MCL Retractor by Askorn Medical — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Askorn Medical
Sources (2)
- FDA UDI 88dbb69c-b9a0-44e6-a645-8d63eb76a8d6 32 fields · synced Jun 20, 2026
- EUDAMED 528671a0-9a7e-478c-a6c9-18b253ec1447 61 fields · synced Jun 20, 2026