← Back to catalogue
Visualase™ Neuro Accessories and Tools
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9736545
by FHC Inc.
Identity
- Trade Name
- Visualase™ Neuro Accessories and Tools EUDAMEDVisualase Anchor Bolt Removal Tool FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Visualase Anchor Bolt Tools, Sterile EUDAMEDVisualase Anchor Bolt Removal Tool (1) Spare Anchor Bolt Removal Tool FDA UDI
- Model / Reference
- 9736545 EUDAMED9736545-00916 FDA UDI
- Description
- Visualase Anchor Bolt Removal Tool (1) Spare Anchor Bolt Removal Tool FDA UDI
Identifiers
- Catalog Number
- 9736545 FDA UDI
- Primary DI / UDI-DI
- 00873263009406 EUDAMED00873263009161 FDA UDI
- Basic UDI-DI
- 087326300.12-101-1-A.TS EUDAMED
- FDA Product Code
- HAO FDA UDI
- EMDN Code
- Z12100685 STEREOTACTIC NEUROSURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 882.4535 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Safe FDA UDI
Visualase™ Neuro Accessories and Tools by Fhc, Inc. — 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 | 087326300.12-101-1-A.TS | 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
- FHC Inc.
- EUDAMED SRN
- US-MF-000012111
- Authorised Representative
- TERMOBIT PROD SRL RO-AR-000010668
Sources (2)
- EUDAMED cea34e40-8743-45ac-b76b-0b867e3a6f8c 61 fields · synced Jul 9, 2026
- FDA UDI f2faa1fd-a7e5-4ae3-afb9-5b35c54e76bd 35 fields · synced May 25, 2026