Catalog Number

SK820000

Brand Name

CoreBloc

Version/Model Number

SK820000

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

9bcd5b99-4370-4f4e-b080-8e8fb72cfc4f

Public Version Date

July 06, 2018

Public Version Number

1

DI Record Publish Date

June 05, 2018

Package DI Number

27350081910093

Quantity per Package

10

Contains DI Package

07350081910099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-