Kerecis® Omega3 SurgiClose™ - Fish-Skin Graft for Surgical Use. Kerecis® Omega3 - KERECIS hf.

Duns Number:365732410

Device Description: Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose™ is indicated for the managem Fish-Skin Graft for Surgical Use. Kerecis® Omega3 SurgiClose™ is indicated for the management of wounds including: Partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), surgical wounds (donor site/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) and draining wounds. IFU: https://www.kerecis.com/ifus/ifu-kerecis-omega3-surgiclose/

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More Product Details

Catalog Number

50205P02D0D

Brand Name

Kerecis® Omega3 SurgiClose™

Version/Model Number

Micro 19 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

K190528,K190528

Product Code Details

Product Code

KGN

Product Code Name

Dressing, Wound, Collagen

Device Record Status

Public Device Record Key

cdaf83c6-112e-455d-83ee-3b14f23ea694

Public Version Date

February 23, 2022

Public Version Number

1

DI Record Publish Date

February 15, 2022

Additional Identifiers

Package DI Number

05694310961547

Quantity per Package

10

Contains DI Package

05694310961530

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