AoN Implants - Drill Cannulated D.2.8 mm. B5. - FAICO MEDICAL LLC

Duns Number:081290972

Device Description: Drill Cannulated D.2.8 mm. B5.

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More Product Details

Catalog Number

-

Brand Name

AoN Implants

Version/Model Number

ACG28IRRDRB50

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

DZA

Product Code Name

Drill, Dental, Intraoral

Device Record Status

Public Device Record Key

98acf41b-8c53-4029-8590-fccc5216beb6

Public Version Date

May 23, 2022

Public Version Number

3

DI Record Publish Date

August 20, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FAICO MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 425
2 A medical device with a moderate to high risk that requires special controls. 1392