Biatain Fiber Ag 33576

GUDID 05708932764568

Coloplast A/S

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID05708932764568
NIH Device Record Keye3aebfc7-744a-4cdd-b184-98aa8b51d8f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Fiber Ag
Version Model Number33576
Catalog Number33576
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

Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch
Width2.5 Centimeter
Length46 Centimeter
Length18 Inch
Width1 Inch

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
GS105708932764513 [Package]
Package: Shipper Box [33 Units]
In Commercial Distribution
GS105708932764568 [Package]
Contains: 05708932764612
Package: Retail Box [5 Units]
In Commercial Distribution
GS105708932764612 [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

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