Tatum EZ-Driver for 4mm Square Sockets - EZ-Driver for 4mm Square Sockets (Short) - will - Suncoast Dental, Inc

Duns Number:078352849

Device Description: EZ-Driver for 4mm Square Sockets (Short) - will fit all brands with 4mm square sockets

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More Product Details

Catalog Number

EZ-Universal Driver Short

Brand Name

Tatum EZ-Driver for 4mm Square Sockets

Version/Model Number

EZ-Driver for 4mm Square Sockets

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

2cb25607-7a06-40f7-b624-af5857d555fc

Public Version Date

February 11, 2021

Public Version Number

2

DI Record Publish Date

December 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUNCOAST DENTAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 405
2 A medical device with a moderate to high risk that requires special controls. 536