Moore Medical - Sterilization Pouch 7.5x13 - MOORE MEDICAL LLC

Duns Number:051420107

Device Description: Sterilization Pouch 7.5x13

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More Product Details

Catalog Number

-

Brand Name

Moore Medical

Version/Model Number

12844

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)

-

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

9ca04d8f-a60d-4ee9-85c2-cfa2e461bae8

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

40607415000069

Quantity per Package

10

Contains DI Package

20607415000058

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