Daniels - MW32 Pharmasmart Container - DANIELS CORPORATION INTERNATIONAL PTY LTD

Duns Number:740491188

Device Description: MW32 Pharmasmart Container

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More Product Details

Catalog Number

-

Brand Name

Daniels

Version/Model Number

1001307516

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K001337

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

60ca8603-d43e-4e16-8ecf-4dcba0727131

Public Version Date

October 10, 2019

Public Version Number

2

DI Record Publish Date

September 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DANIELS CORPORATION INTERNATIONAL PTY LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 24