CATECHOLAMINES LEVEL 3 - CATECHOLAMINES LEVEL 3 - UTAK LABORATORIES, INC.

Duns Number:092519016

Device Description: CATECHOLAMINES LEVEL 3

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More Product Details

Catalog Number

20209

Brand Name

CATECHOLAMINES LEVEL 3

Version/Model Number

20209

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LAS

Product Code Name

Drug Specific Control Materials

Device Record Status

Public Device Record Key

0fea5b42-b28d-424b-896a-4258b7e941a0

Public Version Date

August 03, 2020

Public Version Number

1

DI Record Publish Date

July 24, 2020

Additional Identifiers

Package DI Number

B800202095

Quantity per Package

5

Contains DI Package

B800202090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"UTAK LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 113