Omni-stat Hemostatic Gauze FG07734331

GUDID 75060206630597

Hemostatic Gauze. The device is indicated for: Temporary external treatment to control 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 ID75060206630597
NIH Device Record Key802d279c-0ea5-44b8-81ae-04de5d2040e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni-stat Hemostatic Gauze
Version Model NumberFG07734331
Catalog NumberFG07734331
Company DUNS238476068
Company NameMEDTRADE PRODUCTS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com
Phone+016464178452
Emailinfo@omni-stat.com

Device Dimensions

Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width17 Millimeter
Length120 Millimeter
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS115060206630595 [Primary]
GS135060206630599 [Package]
Contains: 15060206630595
Package: Shelf Carton [10 Units]
In Commercial Distribution
GS175060206630597 [Package]
Contains: 35060206630599
Package: Shipper Case [10 Units]
In Commercial Distribution

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-27
Device Publish Date2020-01-17

On-Brand Devices [Omni-stat Hemostatic Gauze]

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

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