Kerecis® Omega3 MariGen - Fish-skin graft for wound management. Kerecis - KERECIS hf.

Duns Number:365732410

Device Description: Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the manageme Fish-skin graft for wound management. Kerecis Omega3 MariGen is indicated for the management of wounds including: Partial and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds.IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-marigen/

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More Product Details

Catalog Number

50200P01B0D

Brand Name

Kerecis® Omega3 MariGen

Version/Model Number

Micro 8 sq cm

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

K132343,K132343

Product Code Details

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Device Record Status

Public Device Record Key

436f2f8d-7490-4cc1-8114-67c16790745c

Public Version Date

February 25, 2022

Public Version Number

1

DI Record Publish Date

February 17, 2022

Additional Identifiers

Package DI Number

05694310961608

Quantity per Package

10

Contains DI Package

05694310961592

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