Catalog Number

-

Brand Name

ForceBraide

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

82e2b7a7-afad-45a9-9fc9-092511952af5

Public Version Date

February 25, 2021

Public Version Number

6

DI Record Publish Date

January 25, 2017

Package DI Number

B048VAL2020BBT1

Quantity per Package

6

Contains DI Package

B048VAL2020BBT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box