Moore Medical - MB CryoTher Kit 162ml ORM - MOORE MEDICAL LLC

Duns Number:051420107

Device Description: MB CryoTher Kit 162ml ORM

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More Product Details

Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

23499

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)

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

GEH

Product Code Name

Unit, Cryosurgical, Accessories

Device Record Status

Public Device Record Key

a493fb71-7a89-4c2d-9e4b-fff0801894a7

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

40607415001745

Quantity per Package

1

Contains DI Package

10607415001737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

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