TruBrite Adhesive Retractor Light

GUDID 00811331011647

Adhesive Retractor Light

Tz Medical, Inc.

Miniature adhesive light

• Primary Device ID: 00811331011647
• NIH Device Record Key: bb4d5301-0768-4ee6-95b5-74b6506d1b96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruBrite Adhesive Retractor Light
• Version Model Number: ARL-1010
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811331011647 [Unit of Use]
GS1	00811331011654 [Primary]

FDA Product Code

• KYT: Light, Examination, Medical, Battery Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

Devices Manufactured by Tz Medical, Inc.

• 00811331013610 - Retractor Distractor: 2025-02-20 Right alignment distractor
• 00811331013634 - Retractor Distractor: 2025-02-20 Left alignment distractor
• 00811331011470 - ARC Adjustable Radial Cuff: 2023-11-23 ARC Adjustable Radial Cuff- Large
• 00811331011333 - ARC Adjustable Radial Cuff: 2023-11-23 ARC Adjustable Radial Cuff- Small
• 00811331013917 - H3R USB Cable: 2023-11-23 H3R USB Cable
• 00811331013931 - H3R Holster: 2023-11-23 H3R Holster (Rev A)
• 00811331013245 - TZ Medical Pressure Discs: 2023-10-30 Round Universal Disc
• 00811331011210 - EZ Holder: 2023-10-30 EZ Holder