Cuvettes (2400 cuvettes) - Cuvettes (2400 cuvettes) - INSTRUMENTATION LABORATORY COMPANY

Duns Number:557223252

Device Description: Cuvettes (2400 cuvettes)

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More Product Details

Catalog Number

00029400100

Brand Name

Cuvettes (2400 cuvettes)

Version/Model Number

00029400100

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)

Yes

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

GKP

Product Code Name

INSTRUMENT, COAGULATION, AUTOMATED

Device Record Status

Public Device Record Key

7072d4ee-95d6-41e0-a37c-224ec28f4ae5

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION LABORATORY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 272