WOUN'DRES 1166

GUDID 00311701161526

Coloplast A/S

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00311701161526
NIH Device Record Key4e9bf9ce-ab97-455f-8ce7-73175e48f56e
Commercial Distribution StatusIn Commercial Distribution
Brand NameWOUN'DRES
Version Model Number1166
Catalog Number1166
Company DUNS305524696
Company NameColoplast A/S
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce
Total Volume1 Fluid Ounce

Device Identifiers

Device Issuing AgencyDevice ID
GS100311701161021 [Primary]
GS100311701161526 [Package]
Contains: 00311701161953
Package: Shipper Box [6 Units]
In Commercial Distribution
GS100311701161953 [Package]
Contains: 00311701161021
Package: Retail Box [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGQDressing, wound and burn, hydrogel w/drug and/or biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-02
Device Publish Date2022-04-22