Catalog Number

LSW-ZT-425SL-100

Brand Name

PRAMA RF WHITE IMPLANT ZIRTI

Version/Model Number

LSW-ZT-425SL-100

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

K180365

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

6be7ce57-bb92-423b-93f8-5aa18acaaf55

Public Version Date

April 20, 2021

Public Version Number

1

DI Record Publish Date

April 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-