Catalog Number

VLO-1011

Brand Name

Polypropylene, Blue, 2-0, 15cm, Taper Point, 1/2 Circle, 26mm, uni-directional

Version/Model Number

VLO-1011

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

K151112,K151112

Product Code

GAW

Product Code Name

Suture, nonabsorbable, synthetic, polypropylene

Public Device Record Key

ae39edcb-37f2-48c5-82cd-5f0301ce562a

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 30, 2020

Package DI Number

10848782000484

Quantity per Package

12

Contains DI Package

00848782000487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box