microTargeting™ Frame Adapter 66-FA-LX-01

GUDID 00873263001868

Leksell Offsetting Adapter for use with microTargeting Drive

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263001868
• NIH Device Record Key: f46d7a07-29d1-4a16-9206-f665435f54cf
• Commercial Distribution Discontinuation: 2020-02-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Frame Adapter
• Version Model Number: 66-FA-LX-01-00387
• Catalog Number: 66-FA-LX-01
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001868 [Direct Marking]
GS1	00873263003879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011992

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00873263001868]

Hydrogen Peroxide;Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-17

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