Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

SYS0107

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

K190183,K190183,K190183

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

6bd2628b-c3fd-4f63-85e0-c6a070d2b4db

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

G018SYS01LL071

Quantity per Package

100

Contains DI Package

G018SYS01LL070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX