Catalog Number

P701015

Brand Name

PRO ADVANTAGE

Version/Model Number

P701015

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYF

Product Code Name

Cap, Surgical

Public Device Record Key

3041f6ed-e039-4bc0-98e8-a6dbdcdb7d38

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 02, 2022

Package DI Number

M22097010155

Quantity per Package

5

Contains DI Package

M22007010153

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE