Suprathel® - Suprathel® is an absorbable, microporous membrane - Polymedics Innovations GmbH

Duns Number:344089540

Device Description: Suprathel® is an absorbable, microporous membrane and alloplastic skin substitute for the

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More Product Details

Catalog Number

111823-US, 151823-US

Brand Name

Suprathel®

Version/Model Number

Suprathel 18x23

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090160,K090160,K090160

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

bcb0a24c-3c86-4b28-ba65-8a1d1d46802b

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Additional Identifiers

Package DI Number

04260184021475

Quantity per Package

1

Contains DI Package

04260184021437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton envelope

"POLYMEDICS INNOVATIONS GMBH" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 11