Identity
- Trade Name
- Noir® EUDAMEDAESCULAP FDA UDI
- Generic Name
- Craniofacial rongeur, reusable FDA UDI
- Device Name
- Rongeur EUDAMEDRongeur detachable, 150 °, angled upwards, 6" (150 mm), smooth, jaw width: 5 mm, stainless steel FDA UDI
- Model / Reference
- FH905B EUDAMEDFDA UDI
- Description
- Rongeur detachable, 150 °, angled upwards, 6" (150 mm), smooth, jaw width: 5 mm, stainless steel FDA UDI
Identifiers
- Catalog Number
- FH905B FDA UDI
- Primary DI / UDI-DI
- 04046964608384 EUDAMEDFDA UDI
- Basic UDI-DI
- 403923900000051729 EUDAMED
- Direct Marketing DI
- 04046964608384 EUDAMED
- FDA Product Code
- HTX FDA UDI
- EMDN Code
- L110699 NEUROSURGERY FORCEPS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Craniofacial rongeur, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Noir® 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 | 403923900000051729 | 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 15b9f59f-f0a1-4260-ad36-80ea2f909076 61 fields · synced May 31, 2026
- FDA UDI b8ed5b74-db73-4974-b2af-cb3d2d03cb11 35 fields · synced May 27, 2026