WoundClot Hemostatic Gauze 101511901

GUDID 07290016339376

WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.

CORE SCIENTIFIC CREATIONS LTD

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• Primary Device ID: 07290016339376
• NIH Device Record Key: 9e2c4ddb-7e38-49a0-ab3c-5d0d842a3cf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WoundClot Hemostatic Gauze
• Version Model Number: 4"X4" OTC FDA
• Catalog Number: 101511901
• Company DUNS: 600041570
• Company Name: CORE SCIENTIFIC CREATIONS LTD
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com
• Phone: +97237359555
• Email: questions@woundclot.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016339376 [Primary]
GS1	17290016339373 [Package]; Package: BOX [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160679

FDA Product Code

• FRO: Dressing, Wound, Drug
• QSY: Hemostatic Wound Dressing Without Thrombin Or Other Biologics

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: 2021-09-09
• Device Publish Date: 2021-09-01

On-Brand Devices [WoundClot Hemostatic Gauze]

• 17290016339533: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339526: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339519: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339410: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms
• 17290016339403: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms
• 17290016339397: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms
• 17290016339380: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms
• 07290016339376: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms
• 17290016339366: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339304: WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms
• 17290016339274: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339267: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339182: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339175: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339144: WoundClot hemostatic gauz, based on cellulosic structure. In contact with liquids it forms absor
• 17290016339137: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339120: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339113: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 07290016339109: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab
• 17290016339083: WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms ab