OmniTrustTM 9011-43

GUDID 50810572006134

Gauze Sponge, Sterile, 4x4, 8 ply

OMNI INTERNATIONAL CORP.

Woven gauze pad, sterile
Primary Device ID50810572006134
NIH Device Record Key8e3bf503-8bc5-4995-9d60-09fc7f584be4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmniTrustTM
Version Model Number9011-43
Catalog Number9011-43
Company DUNS079434709
Company NameOMNI INTERNATIONAL CORP.
Device Count25
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com
Phone+1(603)471-1499
EmailInfo@Omnigloves.com

Device Dimensions

Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch
Length4 Inch
Width4 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100810572006139 [Primary]
GS110810572006136 [Unit of Use]
GS150810572006134 [Package]
Contains: 00810572006139
Package: Shipper Carton [24 Units]
In Commercial Distribution

FDA Product Code

NABGauze / sponge,nonresorbable for external use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-04
Device Publish Date2019-08-27

On-Brand Devices [OmniTrustTM]

50810572002143Nitrile Examination Glove Powder Free Medium
50810572000866Vinyl Examination Glove Powder Free Small
50810572006363ABD Combine Dressing, Sterile, 8x10
50810572006585Adhesive Bandages, plastic, 1x3
50810572006578Adhesive Bandages, plastic, 3/4x3
50810572006561Drain Sponge, Sterile, 4x4, 6 ply
50810572006554Non-Adherenet Dressing, Sterile, 3x4
50810572006547Non-Adherenet Dressing, Sterile, 2x3
50810572006523Adhesive Bandages, fabric-Blue Metal Detectable, 1x3
50810572006516Adhesive Bandages, clear, 1x3
50810572006509Adhesive Bandages, clear, 3/4x3
50810572006493Adhesive Bandages, fabric, Patch
50810572006486Adhesive Bandages, fabric, spot
50810572006479Adhesive Bandages, fabric, fingertip
50810572006462Adhesive Bandages, fabric, fingertip
50810572006455Adhesive Bandages, fabric, knuckle
50810572006448Adhesive Bandages, fabric, X-Large
50810572006431Adhesive Bandages, fabric, 1x3
50810572006424Adhesive Bandages, fabric, 3/4x3
50810572006417Adhesive Bandages, sheer, Spot
50810572006400Adhesive Bandages, sheer, X-Large
50810572006394Adhesive Bandages, sheer, junior
50810572006387Adhesive Bandages, sheer, 1x3
50810572006370Adhesive Bandages, sheer, 3/4x3
50810572006356ABD Combine Dressing, Sterile, 8x7.5
50810572006349ABD Combine Dressing, Sterile, 5x9
50810572006332Conforming Elastic Bandage, Sterile 6x75
50810572006325Conforming Elastic Bandage, Sterile 4x75
50810572006318Conforming Elastic Bandage, Sterile 3x75
50810572006301Conforming Elastic Bandage, Sterile 2x75
50810572006295Conforming Elastic Bandage, Non-Sterile 6x75
50810572006288Conforming Elastic Bandage, Non-Sterile 4x75
50810572006271Conforming Elastic Bandage, Non-Sterile 3x75
50810572006264Conforming Elastic Bandage, Non-Sterile 2x75
50810572006257Eye Pad, Sterile
50810572006240Non-Woven Sponge, Sterile, 4x4, 4 Ply
50810572006233Non-Woven Sponge, Sterile, 3x3, 4 Ply
50810572006226Non-Woven Sponge, Sterile, 2x2, 4 Ply
50810572006219Non-Woven Sponge, Non-Sterile, 4x4, 4 Ply
50810572006202Non-Woven Sponge, Non-Sterile, 3x3, 4 Ply
50810572006196Non-Woven Sponge, Non-Sterile, 2x2, 4 Ply
50810572006189Gauze Pads, Sterile, 4x4 12 Ply
50810572006172Gauze Pads, Sterile, 3x3, 12 Ply
50810572006165Gauze Pads, Sterile, 2x2, 12 Ply
50810572006158Gauze Sponge, Sterile, 4x4, 12 ply
50810572006141Gauze Sponge, Sterile, 3x3, 12 ply
50810572006134Gauze Sponge, Sterile, 4x4, 8 ply
50810572006127Gauze Sponge, Sterile, 2x2, 8 Ply
50810572006110Gauze Sponge, Non-Sterile, 4x4, 16 Ply
50810572006103Gauze Sponge, Non-Sterile, 4x4, 8 Ply
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.