Catalog Number

DFX0027S

Brand Name

DFX Tensile Tape

Version/Model Number

DFX0027S

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

K153746,K153746

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

ab598d89-85e4-4e3c-87bd-255221b06baf

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2018

Package DI Number

10854629006380

Quantity per Package

12

Contains DI Package

00854629006383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box