US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea - US DIAGNOSTICS Pen Needles are sterile, - YIDOBIO Inc.

Duns Number:689512763

Device Description: US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection nee US DIAGNOSTICS Pen Needles are sterile, non-toxic, non-pyrogenic, single-use injection needles intended for use with all major brands of injection pens. This needle is a device for subcutaneous injection of medicines used for pen type of insulin syringe as subcutaneous injectables.

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More Product Details

Catalog Number

-

Brand Name

US DIAGNOSTICS Pen Needles, 32G x 4MM, 50ea

Version/Model Number

100097

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160575,K160575,K160575,K160575

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

b1306006-1506-44fa-b848-e96e2af69dbe

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 24, 2018

Additional Identifiers

Package DI Number

20857513006333

Quantity per Package

5

Contains DI Package

10857513006336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box