OMNI-STAT Hemostatic Gauze FG04534191

GUDID 35060206630629

Hemostatic Gauze: The device is indicated for: Temporary external treatment for controlling moderate to severe bleeding. Temporary topical dressing for bleeding control associated with minor wounds including control of minor external bleeding and exudate from sutures and/or surgical procedures. Hemostatic gauze is for temporary external use only.

MEDTRADE PRODUCTS LIMITED

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• Primary Device ID: 35060206630629
• NIH Device Record Key: 89e6359a-037a-4065-bac0-0bf83301ce62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNI-STAT Hemostatic Gauze
• Version Model Number: FG04534191
• Catalog Number: FG04534191
• Company DUNS: 238476068
• Company Name: MEDTRADE PRODUCTS LIMITED
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com
• Phone: +016464178452
• Email: info@omni-stat.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 4 Inch
• Width: 4 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060206630625 [Primary]
GS1	35060206630629 [Package]; Contains: 15060206630625; Package: Shelf Carton [10 Units]; In Commercial Distribution
GS1	75060206630627 [Package]; Package: Shipper Case [10 Units]; In Commercial Distribution

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-03-10
• Device Publish Date: 2020-05-28

On-Brand Devices [OMNI-STAT Hemostatic Gauze]

• 75060206630597: Hemostatic Gauze. The device is indicated for: Temporary external treatment to control moderat
• 35060206630629: Hemostatic Gauze: The device is indicated for: Temporary external treatment for controlling mode