Biatain Fiber 33508

GUDID 05708932769426

Coloplast A/S

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID05708932769426
NIH Device Record Key4c6353ee-60ef-43b8-8a6e-4b406a538e75
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiatain Fiber
Version Model Number33508
Catalog Number33508
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

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

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
GS105708932769402 [Primary]
GS105708932769419 [Package]
Contains: 05708932769402
Package: Retail Box [10 Units]
In Commercial Distribution
GS105708932769426 [Package]
Contains: 05708932769419
Package: Shipper Box [21 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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