VSP System - A physical template / guide that is positioned on - 3D SYSTEMS, INC.

Duns Number:085049749

Device Description: A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsa A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), and allows for precise location of predetermined osteotomy planes and holes.

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More Product Details

Catalog Number

-

Brand Name

VSP System

Version/Model Number

Mandible Marking Guide

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

Product Code Details

Product Code

DZJ

Product Code Name

Driver, Wire, And Bone Drill, Manual

Device Record Status

Public Device Record Key

a5ba2a0d-2976-46e3-b089-d2a84f926915

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

September 12, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3D SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 146