Catalog Number

A-ZT-500SP-115

Brand Name

PREMIUM SP IMPLANT ZIRTI

Version/Model Number

A-ZT-500SP-115

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K142242

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

c398c1d7-4c27-45d7-9399-9b3f8d55fc62

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-