Curaplex Advanced Hemostatic Gauze CAHG-4X4

GUDID 01999720000010

Curaplex Hemostatic Gauze, 4 IN X 4 IN, 4-PLY

BOUND TREE MEDICAL, LLC

Chitosan haemostatic agent, professional, non-bioabsorbable

• Primary Device ID: 01999720000010
• NIH Device Record Key: 70ba56df-b982-4827-ad46-788182a68bee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curaplex Advanced Hemostatic Gauze
• Version Model Number: 4in x 4in (10cm x 10cm)
• Catalog Number: CAHG-4X4
• Company DUNS: 070556204
• Company Name: BOUND TREE 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	01999720000003 [Primary]
GS1	01999720000010 [Package]; Contains: 01999720000003; Package: BX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222909

FDA Product Code

• QSY: Hemostatic wound dressing without thrombin or other biologics

Sterilization

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

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

[01999720000010]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-03
• Device Publish Date: 2025-11-25

On-Brand Devices [Curaplex Advanced Hemostatic Gauze]

• 01999720000058: Curaplex Hemostatic Gauze, Z-Fold, 3 IN X 3.2 YD
• 01999720000034: Curaplex Hemostatic Gauze, Rolled, 3 IN X 1.6 YD
• 01999720000010: Curaplex Hemostatic Gauze, 4 IN X 4 IN, 4-PLY