ARC Adjustable Radial Cuff

GUDID 00811331011333

ARC Adjustable Radial Cuff- Small

Tz Medical, Inc.

Radial artery compression device

• Primary Device ID: 00811331011333
• NIH Device Record Key: 788eab65-efbb-4ec7-aa55-f02f7108a649
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARC Adjustable Radial Cuff
• Version Model Number: RCB-0047
• Company DUNS: 793149709
• Company Name: Tz Medical, Inc.
• Device Count: 5
• 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	00811331011333 [Unit of Use]
GS1	00811331011340 [Primary]
GS1	00811331011500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040208

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2023-11-23
• Device Publish Date: 2023-11-15

On-Brand Devices [ARC Adjustable Radial Cuff]

• 00811331011333: ARC Adjustable Radial Cuff- Small
• 00811331011470: ARC Adjustable Radial Cuff- Large