Pink - 0.17oz sachet of silicone based lubricant - Empowered Products, Inc.

Duns Number:784316213

Device Description: 0.17oz sachet of silicone based lubricant intended for use during intercourse or masturbat 0.17oz sachet of silicone based lubricant intended for use during intercourse or masturbation.

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More Product Details

Catalog Number

-

Brand Name

Pink

Version/Model Number

Silicone - Sample

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K152918,K152918

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

503d517e-501d-47f6-b6de-e7bc68a0aa83

Public Version Date

February 17, 2022

Public Version Number

1

DI Record Publish Date

February 09, 2022

Additional Identifiers

Package DI Number

20891306000160

Quantity per Package

50

Contains DI Package

00891306000166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"EMPOWERED PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19