VSP System, VSP Cranial - A three dimensional physical model depicting - 3D SYSTEMS, INC.

Duns Number:085049749

Device Description: A three dimensional physical model depicting patient specific modified anatomy. To be use A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

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More Product Details

Catalog Number

-

Brand Name

VSP System, VSP Cranial

Version/Model Number

Resected Full Skull Model

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

e814db52-be0b-4265-8f78-a0795297b79d

Public Version Date

November 27, 2019

Public Version Number

3

DI Record Publish Date

October 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