Catalog Number

C-SLRA-TRI45

Brand Name

Biodesign

Version/Model Number

G25006

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2021

Issuing Agency

In GS1

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

K070405,K170945

Product Code

OXE

Product Code Name

Mesh, surgical, collagen, staple line reinforcement

Public Device Record Key

d944088e-efd1-4222-9b69-fec5dd1c28cc

Public Version Date

July 30, 2021

Public Version Number

4

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-