Moore Medical - hCG Cassette MMC - MOORE MEDICAL LLC

Duns Number:051420107

Device Description: hCG Cassette MMC

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More Product Details

Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

82790

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"

Yes

For Single-Use

Yes

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

JHI

Product Code Name

Visual, Pregnancy Hcg, Prescription Use

Device Record Status

Public Device Record Key

ad0ac101-5406-4f01-95c7-ab79d15efb17

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

40607415000083

Quantity per Package

40

Contains DI Package

20607415000072

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