Biatain Silicone Ag Sacral 39650

GUDID 05701780210379

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial
Primary Device ID05701780210379
NIH Device Record Key23bb587a-a683-43e2-b583-4ad9f15fab67
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Silicone Ag Sacral
Version Model Number39650
Catalog Number39650
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

Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 Centimeter
Device Size Text, specify0
Length7.5 Inch
Device Size Text, specify0
Width6 Inch
Device Size Text, specify0
Device Size Text, specify0
Length19 Centimeter
Device Size Text, specify0
Width15 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
GS105701780210379 [Package]
Contains: 05701780211437
Package: Retail Box [5 Units]
In Commercial Distribution
GS105701780210386 [Package]
Package: Shipper Box [16 Units]
In Commercial Distribution
GS105701780211437 [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 Sacral]

0570178021039339651
0570178021037939650

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