Catalog Number

-

Brand Name

TRUGLYDE

Version/Model Number

2E70EZ26.5-6

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

7a421b0b-5f88-4f20-aa2a-776cbbb19f78

Public Version Date

December 24, 2021

Public Version Number

2

DI Record Publish Date

April 13, 2018

Package DI Number

18903837040616

Quantity per Package

6

Contains DI Package

08903837040619

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-