Catalog Number

H17-2738N

Brand Name

Fumedica-FSSB

Version/Model Number

H17-2738N

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

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

6cf570a4-69f8-4132-be52-bf67a7bbe797

Public Version Date

August 27, 2021

Public Version Number

1

DI Record Publish Date

August 19, 2021

Package DI Number

10848782044693

Quantity per Package

80

Contains DI Package

00848782044696

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box