VSP System

GUDID 00816847021067

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 ID00816847021067
NIH Device Record Keyeeb4726f-bc2a-4c7c-a2d4-18e89762a5c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameVSP System
Version Model NumberReconstructed Maxilla 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
GS100816847021067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZJDriver, Wire, And Bone Drill, Manual

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

Moist Heat or Steam Sterilization


[00816847021067]

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]

00816847021258A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021241A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021234A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021227A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021203A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021197A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021166A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021159A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021135A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021128A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021104A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021098A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021074A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021067A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021043A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021036A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021012A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847021005A three dimensional physical model depicting patient specific modified anatomy. To be used as p
00816847020985A template that is used as an aide to pre-contour patient’s implants.
00816847020978A template that is used as an aide to pre-contour patient’s implants.
00816847020923A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020916A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020909A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020893A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020886A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020879A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020862A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020855A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020848A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020831A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020824A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020817A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020800A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020794A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020787A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020770A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020732A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020671A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020664A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020657A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020640A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020633A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020626A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020619A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020602A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020596A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020589A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020572A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal),
00816847020565A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all
00816847020558A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all

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