Catalog Number

P903100

Brand Name

PRO ADVANTAGE

Version/Model Number

P903100

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KMJ

Product Code Name

Lubricant, Patient

Public Device Record Key

f83f96e7-041e-4991-8a83-367fca941e60

Public Version Date

October 24, 2022

Public Version Number

1

DI Record Publish Date

October 16, 2022

Package DI Number

M220P9031005

Quantity per Package

12

Contains DI Package

M220P9031003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE