Tatum Surgical/Hand Tool - Hand Tool #31A Driver for 3.5mm angled one piece - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Hand Tool #31A Driver for 3.5mm angled one piece Implant (CBA)

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More Product Details

Catalog Number

HT.31A

Brand Name

Tatum Surgical/Hand Tool

Version/Model Number

Hand Tool / HT.31A

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

NDP

Product Code Name

Accessories, implant, dental, endosseous

Device Record Status

Public Device Record Key

3eb69e2d-2d13-4150-a771-60cf1af5d03f

Public Version Date

December 07, 2020

Public Version Number

2

DI Record Publish Date

April 15, 2018

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