Tatum Surgical/Hand Tool - Hand Tool #30 Integrity .050 Hex driver with - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Hand Tool #30 Integrity .050 Hex driver with handle for Integrity abutments, healing cuffs Hand Tool #30 Integrity .050 Hex driver with handle for Integrity abutments, healing cuffs, cover screws, and 2mm screws

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More Product Details

Catalog Number

HT.30

Brand Name

Tatum Surgical/Hand Tool

Version/Model Number

Hand Tool / HT.30

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

5e49c901-bf0d-482d-a409-6edb5e7fbf38

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