Catalog Number

-

Brand Name

True Comfort Safety Pen Needles 4MM 32G

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K192677,K192677

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

503ff46e-f9a0-4101-85a9-dbe255533b14

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

September 30, 2022

Package DI Number

10850027494446

Quantity per Package

20

Contains DI Package

00850027494449

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton