Catalog Number

-

Brand Name

MONOTEX

Version/Model Number

T8623

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

NBY

Product Code Name

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Public Device Record Key

c38e1ddf-18f1-4f90-922b-3cf456155ae2

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2020

Package DI Number

10810020085034

Quantity per Package

12

Contains DI Package

00810020085037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-