Catalog Number

V392U-S2

Brand Name

Vilet™

Version/Model Number

V392U-S2

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

K120556,K120556

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

882dde16-2509-40dd-9842-1cd3e451a482

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

October 16, 2015

Package DI Number

20841307130618

Quantity per Package

2

Contains DI Package

10841307130611

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Chipboard Carton