Kerecis® Omega3 SurgiBind - Fsh skin for surgical use. INTENDED USE Kerecis® - KERECIS hf.

Duns Number:365732410

Device Description: Fsh skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated for implan Fsh skin for surgical use. INTENDED USE Kerecis® Omega3 SurgiBind™ is indicated for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. https://www.kerecis.com/wp-content/uploads/2021/10/KM-21-0117v2-IFU-Kerecis-SurgiBind.pdf

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More Product Details

Catalog Number

50241G03D0D

Brand Name

Kerecis® Omega3 SurgiBind

Version/Model Number

7x10 cm Fenestrated

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

K202430,K202430

Product Code Details

Product Code

OXH

Product Code Name

Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

Device Record Status

Public Device Record Key

2d8c215e-4edb-4291-aad2-f5b4909cd141

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 11, 2021

Additional Identifiers

Package DI Number

05694310961806

Quantity per Package

10

Contains DI Package

05694310961790

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