Catalog Number

M0790015

Brand Name

Trelon

Version/Model Number

M0790015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 24, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Public Device Record Key

fed4b458-f788-487a-8133-8db4a2c02cb6

Public Version Date

February 28, 2022

Public Version Number

8

DI Record Publish Date

August 26, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-