Catalog Number

KS4215SA-A

Brand Name

KISSES Internal Fixture

Version/Model Number

KS4215SA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K142813

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

6a50d5e2-10d0-427a-bb1d-1122fc864694

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-