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Visualase™ Neuro Accessories and Tools
EUDAMEDFDA UDIClass I (EU MDR)
Ref 9736537
by FHC Inc.
Identity
- Trade Name
- Visualase™ Neuro Accessories and Tools EUDAMEDVisualase Anchor Bolt Tools FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Visualase Anchor Bolt Tools, Non-sterile EUDAMEDVisualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System FDA UDI
- Model / Reference
- 9736537 EUDAMED9736537-00908 FDA UDI
- Description
- Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Autoguide (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame (1) Anchor Bolt Driver Guide for ROSA ONE Brain (1) Anchor Bolt Driver Guide for CRW Stereotactic System FDA UDI
Identifiers
- Catalog Number
- 9736537 FDA UDI
- Primary DI / UDI-DI
- 00873263009321 EUDAMED00873263009086 FDA UDI
- Basic UDI-DI
- 087326300.12-103-1-A.UL EUDAMED
- Direct Marketing DI
- 00873263009321 EUDAMED
- FDA Product Code
- HAO FDA UDI
- EMDN Code
- Z12100680 STEREOTACTIC NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe 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 | 087326300.12-103-1-A.UL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FHC Inc.
- EUDAMED SRN
- US-MF-000012111
- Authorised Representative
- TERMOBIT PROD SRL RO-AR-000010668
Sources (2)
- EUDAMED e8a562b4-d924-436d-aab3-f53265af34c8 61 fields · synced Jul 8, 2026
- FDA UDI c27e817c-3354-47e2-899e-30c8748e3be7 35 fields · synced May 30, 2026