Diamodent - Driver Tip, Square Body.050" Hex - White - DIAMODENT INC

Duns Number:013827410

Device Description: Driver Tip, Square Body.050" Hex - White O-Ring23mm

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

T5615

Brand Name

Diamodent

Version/Model Number

N/A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

DZN

Product Code Name

Instruments, Dental Hand

Device Record Status

Public Device Record Key

f36d6e13-183c-447f-88d6-e3a866028f26

Public Version Date

July 10, 2020

Public Version Number

2

DI Record Publish Date

December 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAMODENT INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 78
2 A medical device with a moderate to high risk that requires special controls. 283