Biatain Silicone Ag 39645

GUDID 05701780210355

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID05701780210355
NIH Device Record Key988a6a33-be8c-4231-92b1-99fbbadb35c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Silicone Ag
Version Model Number39645
Catalog Number39645
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Dimensions

Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length11.8 Inch
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Device Size Text, specify0
Length30 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if package is damaged and consult IFU. Do not resterilize.

Device Identifiers

Device Issuing AgencyDevice ID
GS105701780210355 [Package]
Contains: 05701780211413
Package: Retail Box [5 Units]
In Commercial Distribution
GS105701780210362 [Package]
Package: Shipper Box [20 Units]
In Commercial Distribution
GS105701780211413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-12-08
Device Publish Date2022-11-30

On-Brand Devices [Biatain Silicone Ag]

0570893273059439640
0570893273057039639
0570893273053239638
0570893273050139637
0570893273025939636
0570178021035539645
0570178021034839644

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