Catalog Number

IV-EX52-6010

Brand Name

INVERTA®

Version/Model Number

IV-EX52-6010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K181850

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

4ea3d5f3-8e24-4978-8920-63b36f51e2e3

Public Version Date

September 06, 2022

Public Version Number

2

DI Record Publish Date

November 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-