Pill Club - 12 ct Natural Lubricant - MAYER LABORATORIES, INC.

Duns Number:175425982

Device Description: 12 ct Natural Lubricant

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

36102

Brand Name

Pill Club

Version/Model Number

Natural Lubricant

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, personal

Device Record Status

Public Device Record Key

980e9831-13fb-41a7-b7a4-01e28797e3de

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

Additional Identifiers

Package DI Number

20060004361020

Quantity per Package

1

Contains DI Package

00060004361026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"MAYER LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 6