ALUMINUM BOX_Medium Square - Clean grip for hand & rotary files as well as - DiaDent Group International

Duns Number:687789453

Device Description: Clean grip for hand & rotary files as well as cups for Gutta Percha & Paper Points

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More Product Details

Catalog Number

804-004

Brand Name

ALUMINUM BOX_Medium Square

Version/Model Number

BLUE

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

204d4b8a-003e-4b56-b10b-9520cbd01f1c

Public Version Date

September 02, 2020

Public Version Number

1

DI Record Publish Date

August 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIADENT GROUP INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4806
2 A medical device with a moderate to high risk that requires special controls. 158