Biodesign - Biodesign Staple Line Reinforcement - COOK BIOTECH INCORPORATED

Duns Number:945385862

Device Description: Biodesign Staple Line Reinforcement

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More Product Details

Catalog Number

C-SLRA-60

Brand Name

Biodesign

Version/Model Number

G58396

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

K201000,K201000

Product Code Details

Product Code

FTM

Product Code Name

Mesh, surgical

Device Record Status

Public Device Record Key

1cabe4ba-411d-41ae-94fb-3eb450ae527a

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Additional Identifiers

Package DI Number

10827002583969

Quantity per Package

4

Contains DI Package

00827002583962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX

"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