microTargeting™ LeadLoc Depth Stop 66-AC-DC

GUDID 10873263005665

LeadLoc Depth Stop

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 10873263005665
• NIH Device Record Key: f25bb3c6-04a7-4ded-8ed4-9d43aa97024f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: microTargeting™ LeadLoc Depth Stop
• Version Model Number: 66-AC-DC-00566
• Catalog Number: 66-AC-DC
• 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: true
• 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
• Email: fhcinc@fh-co.com

Device Dimensions

• Lumen/Inner Diameter: 1.6 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005668 [Primary]
GS1	10873263005665 [Package]; Contains: 00873263005668; Package: PK [10 Units]; In Commercial Distribution

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: true

[10873263005665]

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: 2017-01-18

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