Analog - DIGITAL ANALOG UNIVERSAL ABUT. 4.5 X 4.0 - Sin Sistema de Implante Nacional S/A

Duns Number:904569092

Device Description: DIGITAL ANALOG UNIVERSAL ABUT. 4.5 X 4.0

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More Product Details

Catalog Number

ADUA 4540

Brand Name

Analog

Version/Model Number

ADUA 4540

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

6107275e-c1f1-4f91-a8da-3261559578bf

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIN SISTEMA DE IMPLANTE NACIONAL S/A" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1337