Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

SY01LL1

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

f4859c0f-958b-47ba-98b9-12d1008eeb31

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Package DI Number

G018SY01LL11

Quantity per Package

100

Contains DI Package

G018SY01LL10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box