Catalog Number

DFX-2-36-S-WBL-26

Brand Name

Force DFX Suture

Version/Model Number

DFX-2-36-S-WBL-26

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

K150327,K150327

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

28fb5498-4fbf-40bc-a10f-558ebca003ba

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2018

Package DI Number

10854629006489

Quantity per Package

12

Contains DI Package

00854629006482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box