OsteoMed™ Manual Driver Handle 66-WP-DH
GUDID 00873263003237
OsteoMed Manual Driver Handle
FHC, INC.
Neurological stereotactic surgery system| Primary Device ID | 00873263003237 |
| NIH Device Record Key | 55885852-5b45-42e1-8c44-d39c8f3220bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsteoMed™ Manual Driver Handle |
| Version Model Number | 66-WP-DH-00323 |
| Catalog Number | 66-WP-DH |
| Company DUNS | 108179458 |
| Company Name | FHC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com | |
| Phone | +1(800)326-2905 |
| fhcinc@fh-co.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263003237 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K092192
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
[00873263003237]
Moist Heat or Steam Sterilization;Hydrogen Peroxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-07 |
| Device Publish Date | 2016-09-17 |
Devices Manufactured by FHC, INC.
| 00873263009314 - Visualase Neuro Accessories | 2025-12-22 Visualase Neuro Accessories (1) Anchor Bolt (1) Stiffening Stylet (1) Anchor Bolt Removal Tool |
| 00873263009321 - Visualase Anchor Bolt Tools | 2025-12-22 Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Aut |
| 00873263009338 - Visualase MR Stiffening Stylet | 2025-12-22 Visualase MR Stiffening Stylet (1) MR Stiffening Stylet |
| 00873263009345 - Visualase Anchor Bolt Driver | 2025-12-22 Visualase Anchor Bolt Driver (1) Anchor Bolt Driver |
| 00873263009352 - Visualase Anchor Bolt Driver Guide | 2025-12-22 Visualase Anchor Bolt Driver Guide for CRW (1) Anchor Bolt Driver Guide for CRW Stereotactic System |
| 00873263009369 - Visualase Anchor Bolt Driver Guide | 2025-12-22 Visualase Anchor Bolt Guide for Leksell (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame |
| 00873263009376 - Visualase Anchor Bolt Driver Guide | 2025-12-22 Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain |
| 00873263009383 - Visualase Anchor Bolt Driver Guide | 2025-12-22 Visualase Anchor Bolt Driver Guide for Autoguide (1) Anchor Bolt Driver Guide for Stealth Autoguide |
Trademark Results [OsteoMed]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSTEOMED 97627156 not registered Live/Pending |
OsteoMed LLC 2022-10-11 |
 OSTEOMED 76379471 2766295 Live/Registered |
OSTEOMED L.P. 2002-03-06 |
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