CutCure Tube 0.3 fl oz

GUDID 00860010047460

Medcura, Inc.

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00860010047460
• NIH Device Record Key: b5c0397e-ae9c-4b10-9604-a682e6f26375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CutCure Tube 0.3 fl oz
• Version Model Number: 1
• Company DUNS: 808674217
• Company Name: Medcura, 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: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010047460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192667

FDA Product Code

• QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-17
• Device Publish Date: 2023-11-09

Devices Manufactured by Medcura, Inc.

• 00860010047460 - CutCure Tube 0.3 fl oz: 2023-11-17
• 00860010047460 - CutCure Tube 0.3 fl oz: 2023-11-17
• 00860010047477 - CutCure Sachet 0.068 fl oz: 2023-11-17