Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

SYS01250105

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192679,K192679,K192679

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

a11f7dfa-46a8-422e-803d-04b692490c88

Public Version Date

March 11, 2021

Public Version Number

1

DI Record Publish Date

March 03, 2021

Package DI Number

G018SYS012501051

Quantity per Package

100

Contains DI Package

G018SYS012501050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box