Kerecis® Omega3 GraftGuide™ - Fish-Skin Graft for Burn Wound Management. - KERECIS hf.

Duns Number:365732410

Device Description: Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 GraftGuide™ is indicated for th Fish-Skin Graft for Burn Wound Management. Kerecis® Omega3 GraftGuide™ is indicated for the management of wounds including: Partial and full thickness wounds, Trauma wounds including second degree burns, Surgical wounds including donor sites/ grafts.IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-graftguide/

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More Product Details

Catalog Number

50202M04D0D

Brand Name

Kerecis® Omega3 GraftGuide™

Version/Model Number

7x7 cm Meshed

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Device Record Status

Public Device Record Key

21bb3214-dd0d-4af9-90fb-858253ab45ff

Public Version Date

January 27, 2022

Public Version Number

2

DI Record Publish Date

February 15, 2021

Additional Identifiers

Package DI Number

05694310960489

Quantity per Package

10

Contains DI Package

05694310960472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"KERECIS HF." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16
U Unclassified 49