Lower Lead Depth Stop FC8014

GUDID 00873263008362

Lower Lead Depth Stop, 1x with hex wrench

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263008362
• NIH Device Record Key: adae1586-c41b-44a4-b807-14cb85f52fce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lower Lead Depth Stop
• Version Model Number: FC8014-00836
• Catalog Number: FC8014
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263008362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092562

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263008362]

Moist Heat or Steam Sterilization

[00873263008362]

Moist Heat or Steam Sterilization

[00873263008362]

Moist Heat or Steam Sterilization

[00873263008362]

Moist Heat or Steam Sterilization

[00873263008362]

Moist Heat or Steam Sterilization

[00873263008362]

Moist Heat or Steam Sterilization

[00873263008362]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [Lower Lead Depth Stop]

• 00873263008195: Lower Lead Depth Stop, 1x with hex wrench
• 00873263008362: Lower Lead Depth Stop, 1x with hex wrench
• 00873263008508: Lower Lead Depth Stop, 1x with hex wrench