Catalog Number

26-4103

Brand Name

Xive®

Version/Model Number

32264103

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 05, 2020

Issuing Agency

In HIBCC

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

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Public Device Record Key

188c501f-8e4b-458e-882c-340f5650da8a

Public Version Date

January 11, 2021

Public Version Number

3

DI Record Publish Date

July 29, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-