Catalog Number

DFX0029S

Brand Name

Tensile Tape

Version/Model Number

DFX0029S

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153746,K153746

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

5df87482-aa0d-4c13-ab93-34b142b17485

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

July 05, 2018

Package DI Number

10854629006540

Quantity per Package

12

Contains DI Package

00854629006543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box