Catalog Number

1312019

Brand Name

Hexagon

Version/Model Number

1312019

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

K102981

Product Code

DZE

Product Code Name

IMPLANT, ENDOSSEOUS, ROOT-FORM

Public Device Record Key

8471cf6e-c5be-4b23-af17-c93234417b55

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

February 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-