Catalog Number

-

Brand Name

Celling Biosciences Versatile Delivery Kit

Version/Model Number

0861-0003

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

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Public Device Record Key

0affe336-0e28-4ef5-b61d-c9421af13962

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 30, 2017

Package DI Number

10815634020716

Quantity per Package

10

Contains DI Package

00815634020719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-