Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

SN231506

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

K191644,K191644,K191644

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

12619afe-c90e-4371-8df0-182059182c75

Public Version Date

October 25, 2021

Public Version Number

2

DI Record Publish Date

March 25, 2021

Package DI Number

G018SN2315061

Quantity per Package

100

Contains DI Package

G018SN2315060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box