Catalog Number

FG-0028-02

Brand Name

Lariat RS

Version/Model Number

30-06

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

K153096,K153096,K153096,K153096

Product Code

GAT

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyethylene

Public Device Record Key

317871a4-775d-4781-9546-0d9ff00396c2

Public Version Date

August 06, 2021

Public Version Number

1

DI Record Publish Date

July 29, 2021

Package DI Number

30840143903742

Quantity per Package

1

Contains DI Package

10840143904424

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box