Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Wound and vein retractor Ir EUDAMEDGIL VERNET Retractor, 9 1/2", (240 mm), width: 15 mm, non-sterile, reusable FDA UDI
- Model / Reference
- BT214R EUDAMEDFDA UDI
- Description
- GIL VERNET Retractor, 9 1/2", (240 mm), width: 15 mm, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BT214R FDA UDI
- Primary DI / UDI-DI
- 04046963450724 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000119128 EUDAMED
- Direct Marketing DI
- 04046963450724 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L03140105 SKIN 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Aesculap Wound and vein retractor Ir device is a high-quality, Class I medical device designed for surgical procedures. With its durable construction and precise mechanisms, it provides accurate tissue retraction and visualization, making it an ideal tool for both general surgeons and specialized teams.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 403923900000119128 | 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 439f734a-a487-4efd-adca-c647083c62b4 61 fields · synced Jul 21, 2026
- FDA UDI 21621765-3c69-419f-94fb-c37ef404303e 35 fields · synced May 30, 2026