Biatain Fiber 33501

GUDID 05708932769334

Coloplast A/S

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID05708932769334
NIH Device Record Key7419a1d5-5c3b-4364-afe0-e7baaf86157c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Fiber
Version Model Number33501
Catalog Number33501
Company DUNS305524696
Company NameColoplast A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

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
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com
Phone+1(800)533-0464
Emailhealthcarecs@coloplast.com

Device Dimensions

Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 Inch
Length2 Inch
Device Size Text, specify0
Width5 Centimeter
Length5 Centimeter
Width2 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.
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
GS105708932769310 [Primary]
GS105708932769327 [Package]
Contains: 05708932769310
Package: Retail Box [10 Units]
In Commercial Distribution
GS105708932769334 [Package]
Contains: 05708932769327
Package: Shipper Box [60 Units]
In Commercial Distribution

FDA Product Code

NACDressing, wound, hydrophilic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-20
Device Publish Date2024-12-12

On-Brand Devices [Biatain Fiber]

0570893276942633508
0570893276939633506
0570893276936533504
0570893276933433501

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