Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

SYS0106

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

d40ce2a8-0568-4973-bc42-632904f8faa4

Public Version Date

April 02, 2021

Public Version Number

1

DI Record Publish Date

March 25, 2021

Package DI Number

G018SYS01061

Quantity per Package

100

Contains DI Package

G018SYS01060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box