Biatain Silicone Ag 39637

GUDID 05708932730501

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID05708932730501
NIH Device Record Key5bbf2584-088e-4689-95e7-2e49a18b0b03
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Silicone Ag
Version Model Number39637
Catalog Number39637
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
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Width4 Inch
Length4 Inch
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width10 Centimeter
Length10 Centimeter

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
GS105708932730495 [Primary]
GS105708932730501 [Package]
Contains: 05708932730495
Package: Retail Box [5 Units]
In Commercial Distribution
GS105708932730518 [Package]
Package: Shipper Box [48 Units]
In Commercial Distribution

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.