Catalog Number

-

Brand Name

SIS (Luna)

Version/Model Number

BAS00A

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

K123155,K123155

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

c0bcd713-1ec4-4d9f-a882-bd67fb6b9f87

Public Version Date

July 28, 2020

Public Version Number

4

DI Record Publish Date

August 31, 2015

Package DI Number

18809458317154

Quantity per Package

12

Contains DI Package

08809458317157

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box