Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Open-surgery dissector FDA UDI
- Device Name
- HNO retractor Ir EUDAMEDPLESTER Ear Hook, 90 °, angled, 6 1/4", (160 mm), oval tip, width: 0,400 mm, non-sterile, reusable FDA UDI
- Model / Reference
- OG035R EUDAMEDFDA UDI
- Description
- PLESTER Ear Hook, 90 °, angled, 6 1/4", (160 mm), oval tip, width: 0,400 mm, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- OG035R FDA UDI
- Primary DI / UDI-DI
- 04038653176595 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000004762L EUDAMED
- FDA Product Code
- GDG FDA UDI
- EMDN Code
- L149003 ENT RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Open-surgery dissector 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 |
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Manufacturer
- Manufacturer
- Aesculap AG
- EUDAMED SRN
- DE-MF-000005504
Sources (2)
- EUDAMED 0ed2ceb9-0fd9-404e-a633-9893ac30319f 61 fields · synced May 31, 2026
- FDA UDI a3a7652d-e22a-423f-82b6-eab9438a491e 35 fields · synced May 30, 2026