FDA UDI
In Commercial Distribution
🇺🇸 United States
Visualase Anchor Bolt Tools
DI: 00873263009321
·
Model: 9736537-00932
·
FHC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Visualase Anchor Bolt Tools
- Primary DI
- 00873263009321
- Version / Model
- 9736537-00932
- Catalog Number
- 9736537
- Company Name
- FHC, INC.
- Labeler DUNS
- 108179458
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-12
- Public Version
- 1
- Public Version Date
- 2025-12-22
- Public Version Status
- New
- Public Device Record Key
- 2f84b3fc-262a-4e21-bad9-682162753783
Device 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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HAO | INSTRUMENT, SURGICAL, NON-POWERED | Neurology | 882.4535 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32568 | Neurological stereotactic surgery system | An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00873263009321 | GS1 |
Customer Contacts
- Phone
- +1(800)326-2905
- [email protected]