Catalog Number

-

Brand Name

PUBLIX Personal Lubricant

Version/Model Number

7W9

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

-

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

K012203,K012203

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

b0413550-660d-4e45-8ca2-5bef6d0ba121

Public Version Date

October 24, 2019

Public Version Number

1

DI Record Publish Date

October 16, 2019

Package DI Number

10041415055756

Quantity per Package

72

Contains DI Package

00041415055759

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper