Catalog Number

P428661

Brand Name

Pro Advantage

Version/Model Number

P428661

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

GAW

Product Code Name

Suture, Nonabsorbable, Synthetic, Polypropylene

Public Device Record Key

0caa729f-9b28-47a8-bb8c-a723141e1101

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

M220P4286615

Quantity per Package

30

Contains DI Package

M220P5286613

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case