Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Abdominal/bladder/liver retractor IIa EUDAMEDHOLZBACH Center Blade, fenestrated, depth: 74 mm, width: 82 mm, non-sterile, reusable FDA UDI
- Model / Reference
- BV369R EUDAMEDFDA UDI
- Description
- HOLZBACH Center Blade, fenestrated, depth: 74 mm, width: 82 mm, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BV369R FDA UDI
- Primary DI / UDI-DI
- 04038653143511 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000024832X EUDAMED
- Direct Marketing DI
- 04038653143511 EUDAMED
- FDA Product Code
- GAD FDA UDI
- EMDN Code
- L040901 ABDOMINAL SPREADERS, REUSABLE EUDAMED
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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 IIa — 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 | 40392390000024832X | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 6868305a-a95c-462b-b7e1-4812bccd8bd8 61 fields · synced Jul 10, 2026
- FDA UDI 9dbec859-fc48-49fd-87c2-9a1037da4aed 35 fields · synced May 30, 2026