Catalog Number

ZYGEX-32.5

Brand Name

ZYGEX

Version/Model Number

ZYGEX-32.5

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

K173343

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

fa6cae45-dfaa-41ba-8e64-204f1401060c

Public Version Date

September 14, 2022

Public Version Number

2

DI Record Publish Date

November 22, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-