OsteoMed™ Manual Driver Handle 66-WP-DH
GUDID 00873263003237
OsteoMed Manual Driver Handle
FHC, INC.
Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system 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 |
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
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.
| 00873263009208 - microTargeting™ Electrode | 2024-04-22 microTargeting™ Electrode, tungsten, non sterile, 6x, D.ZAP(Z) |
| 10873263009212 - microTargeting™ Electrode | 2024-04-12 microTargeting™ Electrode, tungsten, sterile, D.ZAP(Z) |
| 00873263005453 - microTargeting™ Multi-Oblique Accessory | 2024-03-14 Multi-Oblique Sterilization and Storage Kit |
| 00873263007044 - microTargeting™ Electrode Sterilization Tray | 2024-03-14 microTargeting Electrode Sterilization Tray |
| 00873263002216 - STar™ Drive Frame Adapter Kit | 2024-03-12 STar(TM) Drive Platform Adaptor, Integrated Ring Version |
| 00873263002353 - STar™ Drive Frame Adapter | 2024-03-12 STar(TM) Drive Frame Adapter for use with Brain Lab(R)/Micromar stereotactic frames |
| 00873263002384 - STar™ Drive Positioner | 2024-03-12 Offset Positioner, Short Bushing for STar(TM) Drive |
| 00873263002452 - STar™ Drive Positioner | 2024-03-12 Center Positioner, Short Bushing for STar Drive |
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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