KOVA - 1000 Clear Automation Tubes with Conical Bottom - KOVA INTERNATIONAL, INC.

Duns Number:078780990

Device Description: 1000 Clear Automation Tubes with Conical Bottom

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More Product Details

Catalog Number

87140

Brand Name

KOVA

Version/Model Number

87140

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

NNK

Product Code Name

Container, Specimen Mailer And Storage, Non-Sterile

Device Record Status

Public Device Record Key

d521cb6a-ffe1-4434-ae89-103eb9aa968d

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

August 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOVA INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 114