microTargeting™ Frame Adapter FC1009
GUDID 00873263005873
Radionics CRW Frame Adapter for use with microTargeting Drive
FHC, INC.
Neurosurgical micro targeting drive| Primary Device ID | 00873263005873 |
| NIH Device Record Key | 92a24164-6079-491c-9a1c-49945f310630 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | microTargeting™ Frame Adapter |
| Version Model Number | FC1009-00103 |
| Catalog Number | FC1009 |
| Company DUNS | 108179458 |
| Company Name | FHC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 | |
| 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 |
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 Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
| Storage Environment Temperature | Between -34 Degrees Celsius and 57 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00873263001035 [Primary] |
| GS1 | 00873263005873 [Direct Marking] |
| GS1 | 00873263007372 [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 |
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;Ethylene Oxide
[00873263005873]
Moist Heat or Steam Sterilization;Hydrogen Peroxide;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 | 2016-08-22 |
On-Brand Devices [microTargeting™ Frame Adapter]
| 00873263007389 | Leksell Stereotactic Frame Adapter for use with microTargeting Drive |
| 00873263005873 | Radionics CRW Frame Adapter for use with microTargeting Drive |
| 00873263001844 | Brain Lab/Micromar Frame Adapter for use with microTargeting Drive |
| 00873263001851 | Leksell Frame Adapter for use with microTargeting Drive |
| 00873263001868 | Leksell Offsetting Adapter for use with microTargeting Drive |
| 00873263001875 | Radionics Frame Adapter for use with microTargeting Drive |
| 00873263001882 | Radionics Offsetting Frame Adapter for use with microTargeting Drive |
| 00873263001899 | CRW Expanding Adapter for use with microTargeting Drive |
| 00873263001905 | CRW Expanding Offset Adapter for use with microTargeting Drive |
| 00873263001547 | Leksell Stereotactic Frame Adapter for use with microTargeting Drive |
| 00873263007372 | Radionics CRW Frame Adapter for use with microTargeting 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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