Catalog Number

CER-SUB-1111-OT

Brand Name

CER-SUB-1111-OT

Version/Model Number

11GA X 11CM

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"

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

FGY

Product Code Name

Cannula, Injection

Public Device Record Key

f6d88c41-ecde-482d-8556-6746fe70fe74

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

May 01, 2021

Package DI Number

10850023741032

Quantity per Package

1

Contains DI Package

00850023741035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack