Catalog Number

-

Brand Name

Novafil

Version/Model Number

88864490-51

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

K990952,K990952

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

832d6439-0333-448a-a568-22c171aa9485

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

August 31, 2015

Package DI Number

10884521100633

Quantity per Package

36

Contains DI Package

00884521100636

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE