Catalog Number

-

Brand Name

Walgreens

Version/Model Number

EP364

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070623,K070623,K070623

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

5e9576eb-f794-469b-a190-4b1b55faa83d

Public Version Date

October 05, 2018

Public Version Number

1

DI Record Publish Date

September 04, 2018

Package DI Number

50311917185557

Quantity per Package

24

Contains DI Package

20311917185556

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case