Biatain Silicone Non-Border - Biatain Silicone Non-Border . Non-Border foam - Coloplast A/S

Duns Number:305524696

Device Description: Biatain Silicone Non-Border . Non-Border foam dressing - with soft adhesion for general pu Biatain Silicone Non-Border . Non-Border foam dressing - with soft adhesion for general purposes. Klinikpackung. Dressing Length 7.5 cm, Dressing Length 3 in, Dressing Width 7.5 cm, Dressing Width 3 in.

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More Product Details

Catalog Number

39021

Brand Name

Biatain Silicone Non-Border

Version/Model Number

39021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NAD

Product Code Name

Dressing, wound, occlusive

Device Record Status

Public Device Record Key

17f98e42-8ac5-427a-9fe6-058010b79f0c

Public Version Date

December 22, 2021

Public Version Number

1

DI Record Publish Date

December 10, 2021

Additional Identifiers

Package DI Number

05701780174510

Quantity per Package

10

Contains DI Package

05701780210645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail Box

"COLOPLAST A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 899
3 A medical device with high risk that requires premarket approval 72
U Unclassified 7