microTargeting™ Stylet 66-ST-14P
GUDID 10873263002374
microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive
FHC, INC.
Intracerebral cannula, implantable| Primary Device ID | 10873263002374 |
| NIH Device Record Key | dad32deb-7c8f-46f9-be46-54d4e259e093 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | microTargeting™ Stylet |
| Version Model Number | 66-ST-14P-00237 |
| Catalog Number | 66-ST-14P |
| Company DUNS | 108179458 |
| Company Name | FHC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
Device Dimensions
| Length | 204 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
| Outer Diameter | 1.83 Millimeter |
| Length | 204 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263002377 [Primary] |
| GS1 | 10873263002374 [Package] Contains: 00873263002377 Package: PK/5 [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011775
FDA Product Code
| HAW | Neurological stereotaxic Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
[10873263002374]
Moist Heat or Steam Sterilization;Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-17 |
On-Brand Devices [microTargeting™ Stylet]
| 00873263007112 | microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive |
| 00873263004760 | microTargeting Puncturing Stylet, nonsterile |
| 00873263002438 | microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive |
| 10873263002374 | microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive |
| 10873263008222 | microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar Drive |
| 00873263008256 | microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive |
| 10873263008246 | microTargeting DP Stylet, for use with mT Drive and STar Drive |
Trademark Results [microTargeting]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROTARGETING 78392262 not registered Dead/Abandoned |
TargetPoint Consulting, Inc 2004-03-29 |
 MICROTARGETING 76709829 4259360 Dead/Cancelled |
Siren Interactive Corp. 2011-11-23 |
 MICROTARGETING 74600530 1921303 Dead/Cancelled |
MBV, INC. 1994-11-18 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.