Catalog Number

-

Brand Name

UltraFlo Insulin Pen Needle

Version/Model Number

335772

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

d685c8f5-4a58-4cd5-aae3-d5b9cc109c98

Public Version Date

January 20, 2020

Public Version Number

2

DI Record Publish Date

June 24, 2019

Package DI Number

B7443357723

Quantity per Package

4

Contains DI Package

B7443357722

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton