Biatain Fiber Ag 33570

GUDID 05708932764582

Coloplast A/S

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID05708932764582
NIH Device Record Key19f4f35c-fe22-4075-bb3a-9431e90b576c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Fiber Ag
Version Model Number33570
Catalog Number33570
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latexfalse
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
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0
Length2 Inch
Length5 Centimeter
Width2 Inch
Width5 Centimeter
Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105708932764537 [Package]
Package: Shipper Box [60 Units]
In Commercial Distribution
GS105708932764582 [Package]
Contains: 05708932764636
Package: Retail Box [10 Units]
In Commercial Distribution
GS105708932764636 [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 Date2024-12-02
Device Publish Date2024-11-22

On-Brand Devices [Biatain Fiber Ag]

0570893276458233570
0570893276452033578
0570893276456833576
0570893276455133574
0570893276449033572

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