Catalog Number

CH-ZC-55.0

Brand Name

ZAGA™

Version/Model Number

CH-ZC-55.0

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

K192651

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

8ca2461b-c042-4159-9d4f-858afd1c4642

Public Version Date

September 06, 2022

Public Version Number

2

DI Record Publish Date

November 23, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-