Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- HNO retractor Ir EUDAMEDLUCAE Ear Hook, 90 °, angled, 5 1/2", (140 mm), large, bulb-headed tip, non-sterile, reusable FDA UDI
- Model / Reference
- OF279R EUDAMEDFDA UDI
- Description
- LUCAE Ear Hook, 90 °, angled, 5 1/2", (140 mm), large, bulb-headed tip, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- OF279R FDA UDI
- Primary DI / UDI-DI
- 04038653051045 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000004762L EUDAMED
- FDA Product Code
- GDG FDA UDI
- EMDN Code
- L149003 ENT RETRACTORS, 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Aesculap by Aesculap AG — 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 | 40392390000004762L | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 62b2d892-3b31-4cce-9041-e6f37e84a82e 61 fields · synced May 30, 2026
- FDA UDI 7d4f0f17-47a1-4edb-843e-8009edbc6f3a 35 fields · synced May 30, 2026