Catalog Number

ENT-TRG-2X3

Brand Name

Biodesign

Version/Model Number

G35948

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K121360

Product Code

KHJ

Product Code Name

POLYMER, ENT SYNTHETIC-POLYAMIDE (MESH OR FOIL MATERIAL)

Public Device Record Key

099774f7-56e2-4e88-961c-05b6f22f034d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-