Catalog Number

6-34-530

Brand Name

RI Syringe

Version/Model Number

Air Syringe - SAS SE

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

-

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

K003142

Product Code

MQJ

Product Code Name

Micromanipulators And Microinjectors, Assisted Reproduction

Public Device Record Key

629a019c-3ac5-44d3-b6bf-aabf749b7b9b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-