Catalog Number

B-PD312R19

Brand Name

UNIFY

Version/Model Number

B-PD318R19

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

K193209,K193209,K193209

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

ae7429e7-3b74-4fba-b848-ef04a9d083b2

Public Version Date

August 16, 2022

Public Version Number

2

DI Record Publish Date

February 18, 2022

Package DI Number

10814639025764

Quantity per Package

6

Contains DI Package

00814639025767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box