LeadLoc Depth Stop 66-AC-DCS

GUDID 10873263005207

LeadLoc Depth Stop for St. Jude DBS Leads, non-sterile, 10x

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 10873263005207
• NIH Device Record Key: cc2a46ae-a15c-4812-a66d-6aa21b10b0db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LeadLoc Depth Stop
• Version Model Number: 66-AC-DCS-00520
• Catalog Number: 66-AC-DCS
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 10
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005200 [Unit of Use]
GS1	10873263005207 [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

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

[10873263005207]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-03
• Device Publish Date: 2016-09-17

On-Brand Devices [LeadLoc Depth Stop]

• 10873263005207: LeadLoc Depth Stop for St. Jude DBS Leads, non-sterile, 10x
• 10873263005306: Leadloc Depth Stop for Medtronic DBS Leads, non-sterile, 10x