Catalog Number

DFX0032S

Brand Name

DFX Tensile Tape

Version/Model Number

DFX0032S

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"

Yes

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

51065dfb-4865-4630-ad4f-f2c77d42b52a

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

November 20, 2018

Package DI Number

10854629006656

Quantity per Package

1

Contains DI Package

00854629006659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box