Catalog Number

-

Brand Name

FSSB

Version/Model Number

A016PA

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

-

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

c7277542-6be5-4fbf-afb6-47efcada62b6

Public Version Date

September 02, 2022

Public Version Number

2

DI Record Publish Date

August 01, 2022

Package DI Number

10848782033024

Quantity per Package

12

Contains DI Package

00848782033027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box