VSP System, VSP Cranial

GUDID 00816847021050

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.

3D SYSTEMS, INC.

Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model
Primary Device ID00816847021050
NIH Device Record Keyc539dc4d-b4c2-4f33-9b77-2731e80473d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameVSP System, VSP Cranial
Version Model NumberReconstructed Anatomical Model
Company DUNS085049749
Company Name3D SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com
Phone8446431001
EmailGolden-CustomerService@3DSystems.Com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816847021050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


[00816847021050]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-27
Device Publish Date2016-09-12

On-Brand Devices [VSP System, VSP Cranial]

00816847021463A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021456A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021364Reusable accessory Cutting insert
00816847021357Reusable accessory Cutting insert
00816847021340Reusable accessory Cutting insert
00816847021333Reusable accessory Cutting insert
00816847021326Reusable accessory drill guide
00816847021319Reusable accessory drill guide
00816847021302Reusable accessory drill guide
00816847021296Reusable accessory drill guide
00816847021289A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i
00816847021272A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i
00816847021265A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i
00816847021210A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021180A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021173A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021142A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021111A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021081A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021050A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021029A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847020992A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847020961A physical template that can be positioned at the osteotomy site that allows the physician the a
00816847020954A physical template that can be positioned at the osteotomy site that allows the physician the a
00816847020947A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020930A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020763A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020756A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020749A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of
00816847020725A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020718A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020701A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020695A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020688A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),

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