WoundClot Hemostatic Gauze 101055902

GUDID 17290016339366

WoundClot hemostatic gauze is based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is hemostatic gauze for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required, including traumatic bleeding.

CORE SCIENTIFIC CREATIONS LTD

Plant polysaccharide haemostatic agent, bioabsorbable

• Primary Device ID: 17290016339366
• NIH Device Record Key: 53e1b0d5-fe2c-4953-9fd6-b5ff950c9733
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WoundClot Hemostatic Gauze
• Version Model Number: TWIN PACK 2"X2" FDA
• Catalog Number: 101055902
• Company DUNS: 600041570
• Company Name: CORE SCIENTIFIC CREATIONS LTD
• Device Count: 2
• 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: false

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	07290016339369 [Primary]
GS1	17290016339366 [Package]; Contains: 07290016339369; Package: [10 Units]; In Commercial Distribution
GS1	27290016339363 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140573

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