Catalog Number

1103-329

Brand Name

HEAVY TARTAR HOE

Version/Model Number

1103-329

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

-

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Public Device Record Key

3b3d2a58-68d7-4c3e-ba03-a23889355588

Public Version Date

September 17, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-