microTargeting™ Multi-Oblique Tool Guide 66-MO-20
GUDID 00873263005514
Multi-Oblique Platform 1.7mm Visualase Alignment Rod Guide
FHC, INC.
Neurological stereotactic surgery system| Primary Device ID | 00873263005514 |
| NIH Device Record Key | 20159547-c468-44c3-ad98-1919cb4bd077 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | microTargeting™ Multi-Oblique Tool Guide |
| Version Model Number | 66-MO-20-00551 |
| Catalog Number | 66-MO-20 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 Dimensions
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
| Lumen/Inner Diameter | 1.7 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263005514 [Primary] |
| GS1 | 00873263007181 [Direct Marking] |
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 |
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
[00873263005514]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2018-11-29 |
| Device Publish Date | 2016-12-30 |
On-Brand Devices [microTargeting™ Multi-Oblique Tool Guide]
| 00873263006306 | Multi-Oblique Platform 2.4mm Tool Guide (60mm), 1X |
| 00873263005521 | Multi-Oblique Platform 2.4mm AdTech Bolt Guide |
| 00873263005514 | Multi-Oblique Platform 1.7mm Visualase Alignment Rod Guide |
| 00873263005491 | Multi-Oblique Platform 2.4mm Tool Guide |
| 00873263005484 | Multi-Oblique Platform 2.2mm Tool Guide |
| 00873263005477 | Multi-Oblique Platform 1.8mm Tool Guide |
| 00873263005460 | Multi-Oblique Platform 3.2mm Tool Guide |
| 00873263008096 | Multi-Oblique Platform 3.2mm Tool Guide (60mm), 1X |
| 00873263008621 | Multi-Oblique Platform 2.5mm Tool Guide (60mm), 1X |
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.