Easy Glide INSULIN SYRIN 0.5 ML 30GX5/16" - Easy Glide INSULIN SYRIN 0.5 ML 30GX5/16" - GLOBAL DIABETIC DISTRIBUTORS INC

Duns Number:796779283

Device Description: Easy Glide INSULIN SYRIN 0.5 ML 30GX5/16"

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More Product Details

Catalog Number

-

Brand Name

Easy Glide INSULIN SYRIN 0.5 ML 30GX5/16"

Version/Model Number

630565

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K110421,K110421,K110421,K110421

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

06204fe8-4cbf-46b0-a20d-ebf2c424dad1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Additional Identifiers

Package DI Number

B2086305653

Quantity per Package

6

Contains DI Package

B2086305652

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Case

"GLOBAL DIABETIC DISTRIBUTORS INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 21