Catalog Number

VLP-4144

Brand Name

Quill

Version/Model Number

VLP-4144

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

K132268,K132268

Product Code

NEW

Product Code Name

Suture, surgical, absorbable, polydioxanone

Public Device Record Key

40ab5887-2ace-4998-96e1-1cb91cf78698

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

10848782040121

Quantity per Package

12

Contains DI Package

00848782040124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box