Tatum Serrated Offset Surgical Curette 10S - Serrated Offset double ended Surgical Curette 10S - Suncoast Dental, Inc

Duns Number:078352849

Device Description: Serrated Offset double ended Surgical Curette 10S

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More Product Details

Catalog Number

Curette Off/Serrated 10S

Brand Name

Tatum Serrated Offset Surgical Curette 10S

Version/Model Number

Serrated Offset Surgical Curette 10S

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

FZS

Product Code Name

Curette, Surgical, General Use

Device Record Status

Public Device Record Key

5f68a6a7-8779-40fa-a7b8-927332f1341d

Public Version Date

August 25, 2021

Public Version Number

2

DI Record Publish Date

September 30, 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