microTargeting™ Electrode Sterilization Tray 67-00-1

GUDID 00873263001646

microTargeting Electrode Sterilization Tray

FHC, INC.

Surgical instrument/implant rack

• Primary Device ID: 00873263001646
• NIH Device Record Key: 679dd7b6-136e-4c3f-900d-42104741f9b7
• Commercial Distribution Discontinuation: 2018-10-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: microTargeting™ Electrode Sterilization Tray
• Version Model Number: 67-00-1-00261
• Catalog Number: 67-00-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001646 [Direct Marking]
GS1	00873263002612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033173

FDA Product Code

• GZL: ELECTRODE, DEPTH

Sterilization

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

[00873263001646]

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: 2018-10-30
• Device Publish Date: 2016-09-17

On-Brand Devices [microTargeting™ Electrode Sterilization Tray]

• 00873263007051: microTargeting Electrode Sterilization Tray
• 00873263005880: microTargeting Electrode Sterilization Tray
• 00873263001646: microTargeting Electrode Sterilization Tray
• 00873263007044: microTargeting Electrode Sterilization Tray