Catalog Number

-

Brand Name

Neo Blue Tips

Version/Model Number

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DZM

Product Code Name

Needle, Dental

Public Device Record Key

abddeb60-cef6-418d-ac55-993c6887e393

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Package DI Number

24560128312626

Quantity per Package

2

Contains DI Package

14560128312629

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box