Catalog Number

01N4401

Brand Name

Ultra Safety Plus Twist 30G Short

Version/Model Number

01N4401

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

ae2cafd9-c303-4966-9a36-7230aab78676

Public Version Date

September 26, 2022

Public Version Number

2

DI Record Publish Date

December 23, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-