Catalog Number

-

Brand Name

V SOFT LINE ARTE2 FCN 19Gx100mm

Version/Model Number

4PS119101603G

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172602,K172602,K172602,K172602

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

4e9e9afd-1886-4409-a0cc-881e9701042e

Public Version Date

January 05, 2022

Public Version Number

1

DI Record Publish Date

December 28, 2021

Package DI Number

28800145501709

Quantity per Package

10

Contains DI Package

18800145501702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INBOX