Omni-stat Granules FG07730591

GUDID 15060206630588

Hemostatic Granules. For minor external bleeding from wounds and procedures the device is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. For moderate to severe external bleeding wounds the device is indicated for temporary external treatment for controlling moderate to severe bleeding.

MEDTRADE PRODUCTS LIMITED

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Primary Device ID15060206630588
NIH Device Record Key42079cfd-e596-41ce-a16c-9d5e5ba44684
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni-stat Granules
Version Model NumberFG07730591
Catalog NumberFG07730591
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

Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram

Device Identifiers

Device Issuing AgencyDevice ID
GS115060206630588 [Primary]
GS135060206630582 [Package]
Package: Shelf Carton [10 Units]
In Commercial Distribution
GS175060206630580 [Package]
Contains: 35060206630582
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 Date2019-12-11
Device Publish Date2019-12-03

Devices Manufactured by MEDTRADE PRODUCTS LIMITED

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