Clever Choice Comfort EZ - Insulin Syringe 30G .5cc 5/16" - SIMPLE DIAGNOSTICS INC

Duns Number:004135503

Device Description: Insulin Syringe 30G .5cc 5/16"

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More Product Details

Catalog Number

98302-0139-32

Brand Name

Clever Choice Comfort EZ

Version/Model Number

Insulin Syringe 30G .5cc 5/16"

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

3bb94411-d387-4b10-b189-4bf87fb0c202

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 11, 2016

Additional Identifiers

Package DI Number

10898302139323

Quantity per Package

5

Contains DI Package

00898302139326

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SIMPLE DIAGNOSTICS INC" 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. 19