Identity
- Trade Name
- CranioFix®2 EUDAMEDAESCULAP FDA UDI
- Generic Name
- Dressing/utility forceps, scissors-like, reusable FDA UDI
- Device Name
- CRANIOFIX2 applying forceps EUDAMEDCRANIOFIX2 Applier, 8", (205 mm), non-sterile, reusable FDA UDI
- Model / Reference
- FF494R EUDAMEDFDA UDI
- Description
- CRANIOFIX2 Applier, 8", (205 mm), non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- FF494R FDA UDI
- Primary DI / UDI-DI
- 04038653379620 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000334ZU EUDAMED
- Direct Marketing DI
- 04038653379620 EUDAMED
- FDA Product Code
- GXN FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dressing/utility forceps, scissors-like, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5330 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
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
No
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
CranioFix®2 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 | 4039239000000334ZU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 6a944616-379f-4c51-a962-7625db2812c1 61 fields · synced Jul 19, 2026
- FDA UDI 02c0ace8-53ff-4225-9a14-fed9a62fdcd5 35 fields · synced May 29, 2026