Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

S32310SN1

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"

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

4cd85ca4-61e4-4a42-aa8c-fc0e861ebc24

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

G018S32310SN11

Quantity per Package

100

Contains DI Package

G018S32310SN10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box