TZ Medical, Inc. RAD-1030

GUDID 26975424194742

TZ Medical Peripheral Flipper

EXACT MEDICAL MANUFACTURING, INC.

Patient surgical drape, single-use

• Primary Device ID: 26975424194742
• NIH Device Record Key: 805a0765-4064-47ea-8a70-873ee206b77b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TZ Medical, Inc.
• Version Model Number: RAD-1030
• Catalog Number: RAD-1030
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975424194748 [Primary]
GS1	26975424194742 [Package]; Contains: 06975424194748; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• KPY: Shield, Protective, Personnel

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: 2024-06-10
• Device Publish Date: 2024-06-01

On-Brand Devices [TZ Medical, Inc.]

• 26975424194759: TZ Medical Flipper Shield
• 26975424194742: TZ Medical Peripheral Flipper
• 26975424194735: TZ Medical Halo Flipper