Catalog Number

-

Brand Name

MONOTEX

Version/Model Number

T8665

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

5ed3b7b6-5625-46a3-8cf2-4cfe368f3756

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 16, 2015

Package DI Number

10812444020592

Quantity per Package

12

Contains DI Package

00812444020595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-