ASSURE® ID Insulin 1cc Safety Syringe - Sterile Safety Syringe - ARKRAY USA, INC.

Duns Number:008171162

Device Description: Sterile Safety Syringe

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More Product Details

Catalog Number

-

Brand Name

ASSURE® ID Insulin 1cc Safety Syringe

Version/Model Number

210291

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

K103011,K103011,K103011

Product Code Details

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Device Record Status

Public Device Record Key

6e14eff8-fc0e-41a3-9e43-cc55594f2a38

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

10015482102910

Quantity per Package

100

Contains DI Package

00015482102913

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"ARKRAY USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 30
2 A medical device with a moderate to high risk that requires special controls. 50