Catalog Number

PHB22-493

Brand Name

Fumedica-FSSB

Version/Model Number

PHB22-493

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

K131224,K131224

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Public Device Record Key

f1dd24e2-6bd4-46b9-9279-5bb7e6535375

Public Version Date

August 29, 2022

Public Version Number

2

DI Record Publish Date

August 19, 2021

Package DI Number

10848782044686

Quantity per Package

36

Contains DI Package

00848782044689

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box