AoN Implants - Standard Pivot Processing Pack Assembly - PVD - FAICO MEDICAL LLC

Duns Number:081290972

Device Description: Standard Pivot Processing Pack Assembly - PVD Cap, OverDLock Attachment System

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More Product Details

Catalog Number

-

Brand Name

AoN Implants

Version/Model Number

LOC50002

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

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

b8feda31-1468-4871-9fe7-e9b895e4939f

Public Version Date

December 27, 2021

Public Version Number

1

DI Record Publish Date

December 18, 2021

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