Topco Contact Lens Case - TOPCO ASSOCIATES, LLC

Duns Number:072943876

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More Product Details

Catalog Number

003680035406

Brand Name

Topco Contact Lens Case

Version/Model Number

K1010TC

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

LRX

Product Code Name

Case, Contact Lens

Device Record Status

Public Device Record Key

74576b3f-4dee-4397-a78f-c0500718ca41

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 07, 2016

Additional Identifiers

Package DI Number

10036800354064

Quantity per Package

6

Contains DI Package

20023185002496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"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