Catalog Number

-

Brand Name

ForceBraid™

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

K100506,K100506

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

8bf5ae43-1dc3-40f3-8ee3-1824ea6466b8

Public Version Date

February 25, 2021

Public Version Number

6

DI Record Publish Date

December 15, 2015

Package DI Number

B048VAL0236GL1

Quantity per Package

10

Contains DI Package

B048VAL0236GL0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box