TRAUMAGEL ®

GUDID 00860007891144

Hemostatic Gel

Cresilon, Inc.

Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00860007891144
• NIH Device Record Key: 51a41f09-8700-4fe5-8b0e-fde94f55bc11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRAUMAGEL ®
• Version Model Number: TG-0001
• Company DUNS: 035745047
• Company Name: Cresilon, 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: 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	00860007891144 [Primary]
GS1	00860007891151 [Package]; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240713

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: 2024-10-16
• Device Publish Date: 2024-10-08