Kerecis® Omega3 BURN - Acellular fish skin for topical and surgical - KERECIS hf.

Duns Number:365732410

Device Description: Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated Acellular fish skin for topical and surgical wounds.INTENDED USEKerecis® Burn is indicated for the management of wounds including: - Partial and full-thickness wounds, - Trauma wounds (abrasions, lacerations, second-degree burns, skin tears).MeshedDouble Pouchedhttps://www.kerecis.com/wp-content/uploads/2020/10/A5-KM-19-0146-IFU-Kerecis-Burn-US.pdf

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More Product Details

Catalog Number

50202M13B0D

Brand Name

Kerecis® Omega3 BURN

Version/Model Number

7x10 Meshed Burn

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

4b15a4b4-8161-4ce6-8262-327fa1270762

Public Version Date

February 23, 2021

Public Version Number

1

DI Record Publish Date

February 15, 2021

Additional Identifiers

Package DI Number

05694310960021

Quantity per Package

5

Contains DI Package

05694310960014

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