Fortify - Fortify TRG Tissue Repair Graft - COOK BIOTECH INCORPORATED

Duns Number:945385862

Device Description: Fortify TRG Tissue Repair Graft

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More Product Details

Catalog Number

FTRG-4X7-S

Brand Name

Fortify

Version/Model Number

G59064

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"

-

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

K191696,K980431

Product Code Details

Product Code

FTM

Product Code Name

Mesh, surgical

Device Record Status

Public Device Record Key

86f6e6ff-8a21-4c04-bff5-4f36111df541

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK BIOTECH INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 116
U Unclassified 36