Catalog Number

-

Brand Name

Zuga

Version/Model Number

GST-350-000

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

-

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

K122664

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

0b59dcb4-ceac-47bb-a92c-45bc1f969403

Public Version Date

January 09, 2020

Public Version Number

5

DI Record Publish Date

January 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-