Catalog Number

-

Brand Name

MediDent

Version/Model Number

1

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

9f541786-ef3f-4aee-b993-6bcb908f214f

Public Version Date

February 04, 2021

Public Version Number

1

DI Record Publish Date

January 27, 2021

Package DI Number

16971911290471

Quantity per Package

100

Contains DI Package

06971911290474

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box