Blossom Organics - Personal Lubricant 4 fl. oz. - MAYER LABORATORIES, INC.

Duns Number:175425982

Device Description: Personal Lubricant 4 fl. oz.

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More Product Details

Catalog Number

53004

Brand Name

Blossom Organics

Version/Model Number

Natural

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

-

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

97c8c12f-95be-454d-ba7d-f26a85c59288

Public Version Date

December 06, 2021

Public Version Number

6

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

20016169530047

Quantity per Package

6

Contains DI Package

00016169530043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHRINK WRAP

"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