Identity
- Trade Name
- CranioFix®2 EUDAMEDAESCULAP FDA UDI
- Generic Name
- Dressing/utility forceps, scissors-like, reusable FDA UDI
- Device Name
- CRANIOFIX2 forceps EUDAMEDCRANIOFIX2 Cutting Forceps, 5 3/4", (145 mm), non-sterile, reusable FDA UDI
- Model / Reference
- FF103R EUDAMEDFDA UDI
- Description
- CRANIOFIX2 Cutting Forceps, 5 3/4", (145 mm), non-sterile, reusable FDA UDI
Identifiers
- Catalog Number
- FF103R FDA UDI
- Primary DI / UDI-DI
- 04038653163069 EUDAMEDFDA UDI
- Basic UDI-DI
- 4039239000000335ZW EUDAMED
- Direct Marketing DI
- 04038653163069 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
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
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 | 4039239000000335ZW | 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 f1dca499-a4ac-4beb-81fd-09a6335e0d96 61 fields · synced Jul 11, 2026
- FDA UDI 87b4530f-a610-4ac9-abb6-80acb4bd81c0 35 fields · synced May 29, 2026