Sharps Crate - DYNAREX CORPORATION

Duns Number:008124539

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More Product Details

Catalog Number

-

Brand Name

Sharps Crate

Version/Model Number

4631

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

K082042,K082042

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

6c8368bd-37b5-4e14-8490-94a50b64145f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 16, 2017

Additional Identifiers

Package DI Number

00616784463131

Quantity per Package

40

Contains DI Package

00616784463117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2