Catalog Number

-

Brand Name

UNIFY PP Surgical Sutures

Version/Model Number

XXL-P230K60

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000537,K080684,K000537,K080684,K000537,K080684

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

3a376856-e3ed-45ba-a67a-e43d347ccdb9

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

January 01, 2017

Package DI Number

20814639023224

Quantity per Package

100

Contains DI Package

10814639023227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case