Catalog Number

-

Brand Name

HAPTITE s-Clean SAVE Fixture

Version/Model Number

DSFS6507HS

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

K111364

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

95f16aa7-b538-4a69-baa9-caad05203d53

Public Version Date

May 26, 2021

Public Version Number

3

DI Record Publish Date

May 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-