EXCALIBUR - DISTAL END CUTTER - Gc Orthodontics America Inc.

Duns Number:063167128

Device Description: DISTAL END CUTTER

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More Product Details

Catalog Number

GCO-1016U

Brand Name

EXCALIBUR

Version/Model Number

GCO-1016U

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Device Record Status

Public Device Record Key

a3926f95-fd9a-4a94-93ac-44693d21406a

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GC ORTHODONTICS AMERICA INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1781
2 A medical device with a moderate to high risk that requires special controls. 215