TOPCARE - MINI SHIELD SCENTED 22CNT - TOPCO ASSOCIATES, LLC

Duns Number:072943876

Device Description: MINI SHIELD SCENTED 22CNT

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More Product Details

Catalog Number

-

Brand Name

TOPCARE

Version/Model Number

10003432

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

-

Product Code Details

Product Code

NRC

Product Code Name

Pads, Menstrual, Scented-Deodorized

Device Record Status

Public Device Record Key

481463bb-5384-48d8-88b9-9066962c60ea

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 03, 2020

Additional Identifiers

Package DI Number

10036800116877

Quantity per Package

18

Contains DI Package

00036800116870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case

"TOPCO ASSOCIATES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 29
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 1