Catalog Number

682251

Brand Name

SY10-RT

Version/Model Number

682251

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

DQF

Product Code Name

Actuator, Syringe, Injector Type

Public Device Record Key

976e3985-b455-471f-9395-970445caf8d2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Package DI Number

50886333622516

Quantity per Package

50

Contains DI Package

00886333622511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek Bag