Catalog Number

-

Brand Name

SOL-M™ Hypodermic Needle

Version/Model Number

113112

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"

Yes

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

83304ac3-af1e-448e-b8e2-6a4c548b65a7

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

October 23, 2017

Package DI Number

20818392012754

Quantity per Package

10

Contains DI Package

10818392012757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case