Catalog Number

VLP-4145

Brand Name

Quill

Version/Model Number

VLP-4145

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

5adb8f5a-02bc-4b05-9af3-ffe0c65b6e5e

Public Version Date

April 13, 2021

Public Version Number

1

DI Record Publish Date

April 05, 2021

Package DI Number

10848782040138

Quantity per Package

12

Contains DI Package

00848782040131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box