StopsBleeding™

GUDID 00850817006470

StopsBleeding™ Dental Foam

Coag Medical, LLC

Plant polysaccharide haemostatic agent, bioabsorbable

• Primary Device ID: 00850817006470
• NIH Device Record Key: ca6382ca-3567-490d-a6c6-a61ac558f59d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StopsBleeding™
• Version Model Number: SBP000D
• Company DUNS: 079736884
• Company Name: Coag Medical, LLC
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850817006470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140313

FDA Product Code

• LYA: Splint, Intranasal Septal

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: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [StopsBleeding™]

• 00850817006470: StopsBleeding™ Dental Foam
• 00850817006456: StopsBleeding™ 10g pouch
• 00850817006234: StopsBleeding™ 150g pouch
• 00850817006227: StopsBleeding™ 60g pouch
• 00850817006210: StopsBleeding™ 20g pouch
• 00850817006197: StopsBleeding™ Nose Bleed Foam Strip