ID Millennium - ID Millennium is a Silicone based lubricant, and - WESTRIDGE LABORATORIES INCORPORATED

Duns Number:879057065

Device Description: ID Millennium is a Silicone based lubricant, and is Latex Compatible.

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More Product Details

Catalog Number

IDDMIP03

Brand Name

ID Millennium

Version/Model Number

Millennium 3 ml Pillow

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141767,K141767,K141767,K141767

Product Code Details

Product Code

NUC

Product Code Name

Lubricant, Personal

Device Record Status

Public Device Record Key

dfabebe9-c564-49be-8539-f9e2ced78583

Public Version Date

August 07, 2020

Public Version Number

5

DI Record Publish Date

January 23, 2017

Additional Identifiers

Package DI Number

50761236109893

Quantity per Package

1000

Contains DI Package

00761236109898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WESTRIDGE LABORATORIES INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 56