TZ Medical Pressure Discs

GUDID 00811331011838

Large Round Universal Disc w/ Omega opening

Tz Medical, Inc.

Femoral artery compression system, manual, single-use

• Primary Device ID: 00811331011838
• NIH Device Record Key: fd21296e-b244-4ade-af1d-77d0c3ca9087
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TZ Medical Pressure Discs
• Version Model Number: 8880-06
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 50
• 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: 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	00811331011838 [Unit of Use]
GS1	00811331011845 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914149

FDA Product Code

• DXC: Clamp, Vascular

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

On-Brand Devices [TZ Medical Pressure Discs]

• 00811331013252: Oval Universal Disc w/ Omega opening
• 00811331010480: Round Universal Disc w/ Omega opening
• 00811331011838: Large Round Universal Disc w/ Omega opening
• 00811331011715: Oval Universal Disc
• 00811331013245: Round Universal Disc