Catalog Number

S019

Brand Name

Single Use Surgical Professional

Version/Model Number

S019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

5884b915-ea4a-419b-96bf-4db613a2878a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 19, 2016

Package DI Number

05055299100219

Quantity per Package

25

Contains DI Package

05055299100981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton