SCHICK33 - SCHICK33 S0 SENSOR SHIP KIT 9 FT - SIRONA DENTAL, INC.

Duns Number:078613913

Device Description: SCHICK33 S0 SENSOR SHIP KIT 9 FT

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More Product Details

Catalog Number

-

Brand Name

SCHICK33

Version/Model Number

B1318001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

EAP

Product Code Name

Unit, X-Ray, Intraoral

Device Record Status

Public Device Record Key

28cf7ba7-cfd6-4a7b-9fd8-2d41a48b0ceb

Public Version Date

January 29, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIRONA DENTAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 461