GEORGE 2MM BITE FORK - GEORGE 2MM BITE FORK - Great Lakes Dental Technologies, Ltd.

Duns Number:041854332

Device Description: GEORGE 2MM BITE FORK

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More Product Details

Catalog Number

056-023

Brand Name

GEORGE 2MM BITE FORK

Version/Model Number

056-023

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

Yes

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

EHY

Product Code Name

Tray, Impression, Preformed

Device Record Status

Public Device Record Key

b9053f1d-0704-4903-9c3b-19fcf74f8aa5

Public Version Date

February 02, 2021

Public Version Number

3

DI Record Publish Date

May 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GREAT LAKES DENTAL TECHNOLOGIES, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 183