NobelProcera® - NPr Ab Ti for Zimmer Hex 3.5 w-u - Nobel Biocare AB

Duns Number:353939929

Device Description: NPr Ab Ti for Zimmer Hex 3.5 w-u

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More Product Details

Catalog Number

70166

Brand Name

NobelProcera®

Version/Model Number

70166

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 08, 2020

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

c665b3be-d4f2-4211-938a-1a5bc2167cdc

Public Version Date

November 02, 2020

Public Version Number

8

DI Record Publish Date

September 17, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOBEL BIOCARE AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 782
2 A medical device with a moderate to high risk that requires special controls. 3680