Ultra-Care Insulin Syringe 30G 5/16" 0.3 CC 100 Ct - Ultra-Care Insulin Syringe 30G 5/16" 0.3 CC 100 Ct - ARISE MEDICAL LLC

Duns Number:081149273

Device Description: Ultra-Care Insulin Syringe 30G 5/16" 0.3 CC 100 Ct

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More Product Details

Catalog Number

-

Brand Name

Ultra-Care Insulin Syringe 30G 5/16" 0.3 CC 100 Ct

Version/Model Number

240401

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

-

Product Code Details

Product Code

FMF

Product Code Name

Syringe, Piston

Device Record Status

Public Device Record Key

f765f6b7-d2a1-4653-b6b1-a27e684f9ecb

Public Version Date

January 20, 2020

Public Version Number

2

DI Record Publish Date

November 29, 2018

Additional Identifiers

Package DI Number

00372217007289

Quantity per Package

5

Contains DI Package

00372217007036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ARISE MEDICAL LLC" 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. 17