Catalog Number

-

Brand Name

SecureSafe Safety Hypodermic Needles

Version/Model Number

8964

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)

Yes

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

K142765,K142765

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

fb0bab18-4746-4737-ad94-f203a6c15513

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

October 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-