Catalog Number

-

Brand Name

Syneture

Version/Model Number

VLOCN2145

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

K103052,K103052

Product Code

GAT

Product Code Name

SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Public Device Record Key

bab5f301-2c47-47e1-9eae-dfc6a71ebbdf

Public Version Date

February 07, 2022

Public Version Number

7

DI Record Publish Date

March 21, 2018

Package DI Number

20884521762562

Quantity per Package

12

Contains DI Package

10884521762565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE