Identity
- Trade Name
- Aesculap EUDAMEDFDA UDI
- Generic Name
- Scalpel handle, reusable FDA UDI
- Device Name
- Scalpel EUDAMEDBARRE Scalpel Handle, 12 °, angled, 9 3/4", (250 mm), No. 3 XL, non-sterile, reusable FDA UDI
- Model / Reference
- BB176R EUDAMEDFDA UDI
- Description
- BARRE Scalpel Handle, 12 °, angled, 9 3/4", (250 mm), No. 3 XL, non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- BB176R FDA UDI
- Primary DI / UDI-DI
- 04046963103835 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000403ZN EUDAMED
- Direct Marketing DI
- 04046963103835 EUDAMED
- FDA Product Code
- GDZ FDA UDI
- EMDN Code
- L010103 HANDLES FOR SCALPELS, REUSABLE EUDAMED
- GMDN Term
- Scalpel handle, 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 | 4039239000000403ZN | 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 a488a235-f4f7-4ec0-9aec-15b892f5a473 61 fields · synced Jul 26, 2026
- FDA UDI f969b9ab-bdbf-4768-8d92-06b723a679f2 35 fields · synced May 30, 2026