TopCare health - TOPCO ASSOCIATES, LLC

Duns Number:072943876

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More Product Details

Catalog Number

-

Brand Name

TopCare health

Version/Model Number

60002723

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

-

Product Code Details

Product Code

DWL

Product Code Name

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Device Record Status

Public Device Record Key

36e802ac-a080-4cb5-a6db-fa2259d0476a

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Additional Identifiers

Package DI Number

20036800649600

Quantity per Package

6

Contains DI Package

00036800649606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack

"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