Tatum Surgical/Hand Tool - Hand Tool #15 Driver for 3.5mm one piece Implant - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Hand Tool #15 Driver for 3.5mm one piece Implant (CB)

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More Product Details

Catalog Number

HT.15

Brand Name

Tatum Surgical/Hand Tool

Version/Model Number

Hand Tool / HT.15

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

41d810dc-4a49-4a03-a74c-7730c3305b3f

Public Version Date

December 04, 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