STA® - Cleaner Solution - DIAGNOSTICA STAGO

Duns Number:262277122

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More Product Details

Catalog Number

-

Brand Name

STA® - Cleaner Solution

Version/Model Number

00973

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

PPM

Product Code Name

General purpose reagent

Device Record Status

Public Device Record Key

2a3559b2-6225-4a8b-be2d-cd56be9e9ad4

Public Version Date

July 27, 2022

Public Version Number

3

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

13607450009733

Quantity per Package

6

Contains DI Package

03607450009736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DIAGNOSTICA STAGO" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 57