IMMY - MycoDDR Prep Blue 3.0% - Immuno-Mycologics, Inc.

Duns Number:099550915

Device Description: MycoDDR Prep Blue 3.0%

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More Product Details

Catalog Number

-

Brand Name

IMMY

Version/Model Number

MPB075-3.0

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

PPM

Product Code Name

General Purpose Reagent

Device Record Status

Public Device Record Key

f68c7279-a256-411b-8d97-65c5afc7edb2

Public Version Date

March 28, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IMMUNO-MYCOLOGICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 32