microTargeting™ Frame Adapter FC1009

GUDID 00873263007372

Radionics CRW Frame Adapter for use with microTargeting Drive

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263007372
• NIH Device Record Key: 4dc8c878-c9eb-4a8b-bc29-529af9bc5e19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ Frame Adapter
• Version Model Number: FC1009-00737
• 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
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: 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

Device Identifiers

Device Issuing Agency	Device ID
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

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

[00873263007372]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-05-22
• Device Publish Date: 2019-01-18

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