Comfort EZ - Insulin Syringe - 100 count - S.D.I. USA, INC.

Duns Number:116722847

Device Description: Insulin Syringe - 100 count

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More Product Details

Catalog Number

50002-0860-19

Brand Name

Comfort EZ

Version/Model Number

i31156

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

6431c535-b0ca-45ed-924c-cc22ce5590d0

Public Version Date

January 25, 2019

Public Version Number

2

DI Record Publish Date

October 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S.D.I. USA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3