Bondable Buccal - ROTH SGL 022/LR7-25T 6OF - Gc Orthodontics America Inc.

Duns Number:063167128

Device Description: ROTH SGL 022/LR7-25T 6OF

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More Product Details

Catalog Number

40-2470-0012

Brand Name

Bondable Buccal

Version/Model Number

40-2470-0012

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

EJF

Product Code Name

BRACKET, METAL, ORTHODONTIC

Device Record Status

Public Device Record Key

4a025be7-1773-48ee-9356-9b82e02269f5

Public Version Date

February 24, 2020

Public Version Number

1

DI Record Publish Date

February 14, 2020

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