Biatain Ag Adhesive 9635

GUDID 05708932369732

Coloplast A/S

Exudate-absorbent dressing, non-gel, antimicrobial

Primary Device ID	05708932369732
NIH Device Record Key	b309ed1c-4461-4a7f-8afd-be54e4467f4d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Biatain Ag Adhesive
Version Model Number	9635
Catalog Number	9635
Company DUNS	305524696
Company Name	Coloplast A/S
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Width	18 Centimeter
Device Size Text, specify	0
Length	7 Inch
Width	7 Inch
Device Size Text, specify	0
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Width	7 Inch
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Device Size Text, specify	0
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Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0
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Width	7 Inch
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Width	7 Inch
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Width	7 Inch
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Width	7 Inch
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Width	7 Inch
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Length	18 Centimeter
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Device Size Text, specify	0
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Width	7 Inch
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Length	18 Centimeter
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Device Size Text, specify	0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932369725 [Package] Contains: 05708932488839 Package: Retail Box [5 Units] In Commercial Distribution
GS1	05708932369732 [Package] Contains: 05708932369725 Package: Shipper Box [16 Units] In Commercial Distribution
GS1	05708932488839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K100218

FDA Product Code

FRO	Dressing, wound, drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-13
Device Publish Date	2022-12-05

On-Brand Devices [Biatain Ag Adhesive]

05708932442121	9643
05708932369732	9635
05708932442107	9641