Intimaterial Silicone Personal Lubricant - SILICONE Personal Lubricant is a personal - Premium Natural Cosmetics Inc.

Duns Number:051403646

Device Description: SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

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More Product Details

Catalog Number

-

Brand Name

Intimaterial Silicone Personal Lubricant

Version/Model Number

00860006114107

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

-

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

K191654

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

7ab77e09-b961-4fd5-b3ea-e17a91e59617

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PREMIUM NATURAL COSMETICS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2