Catalog Number

58884012

Brand Name

ORTHOLOC 3DI PLATING SYSTEM

Version/Model Number

58884012

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

-

Product Code

HXD

Product Code Name

CLAMP

Public Device Record Key

eb44ee16-8502-4405-819d-675d12f9df42

Public Version Date

September 26, 2022

Public Version Number

4

DI Record Publish Date

December 19, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-