Catalog Number

-

Brand Name

Doctors Choice

Version/Model Number

SYSR03251502

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

MEG

Product Code Name

Syringe, Antistick

Public Device Record Key

ebe0c70c-a4b6-461c-87e0-0f4d89c97774

Public Version Date

March 25, 2021

Public Version Number

2

DI Record Publish Date

February 03, 2021

Package DI Number

G018SYSR032515021

Quantity per Package

100

Contains DI Package

G018SYSR032515020

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX