microTargeting™ Stylet 66-ST-17
GUDID 00873263007112
microTargeting DP Stylet, nonsterile, for use with mT Drive and STar Drive
FHC, INC.
Intracerebral cannula, nonimplantable, single-use Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable Scalpel, reusable| Primary Device ID | 00873263007112 |
| NIH Device Record Key | 4d9a6e49-9d00-445c-bb15-d131f0727d3b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | microTargeting™ Stylet |
| Version Model Number | 66-ST-17-00711 |
| Catalog Number | 66-ST-17 |
| Company DUNS | 108179458 |
| Company Name | FHC, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 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
| Outer Diameter | 1.55 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 Millimeter |
| Length | 211 Millimeter |
| Outer Diameter | 1.55 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 |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage 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 | 00873263007112 [Primary] |
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 | false |
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00873263007112]
Moist Heat or Steam Sterilization;Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-21 |
| Device Publish Date | 2018-11-20 |
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 |
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