VSP System, VSP Cranial - Reusable accessory drill guide - 3D SYSTEMS, INC.

Duns Number:085049749

Device Description: Reusable accessory drill guide

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More Product Details

Catalog Number

-

Brand Name

VSP System, VSP Cranial

Version/Model Number

Drill Guide (2.0 mm Screws)

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

-

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

fb30e4fb-97dd-4cce-8d02-5ec16481afed

Public Version Date

April 06, 2020

Public Version Number

4

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