Catalog Number

-

Brand Name

ForceBraid™

Version/Model Number

VAL2020WT

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

K150438,K150438

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

720f82eb-5c4c-4e22-9975-6c8052288ab8

Public Version Date

February 25, 2021

Public Version Number

6

DI Record Publish Date

August 17, 2017

Package DI Number

10818614020744

Quantity per Package

6

Contains DI Package

00818614020747

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box