SupraSDRM® - SupraSDRM® is an absorbable, microporous - Polymedics Innovations GmbH

Duns Number:344089540

Device Description: SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management SupraSDRM® is an absorbable, microporous biodegradable matrix indicated for the management of superficial dermal wounds, split-skin graft donor sites, pressure and venous ulcers, and 2nd degree burns. The biodegradable matrix is designed for trauma and surgical wounds involving soft tissues. The SupraSDRM matrix is available in various sizes for use in covering and protecting superficial and partial thickness soft tissue wounds.

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More Product Details

Catalog Number

310202-US

Brand Name

SupraSDRM®

Version/Model Number

SupraSDRM 2x2

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

K170213,K170213

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

d8d5ac98-ea2b-4744-9596-0c20e00d5473

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Additional Identifiers

Package DI Number

04260184023035

Quantity per Package

1

Contains DI Package

04260184023028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box

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