| Primary Device ID | 00816847021142 |
| NIH Device Record Key | 2a389fc8-488f-445d-8ef7-804452050782 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VSP System, VSP Cranial |
| Version Model Number | Repositioned Full Skull Model |
| Company DUNS | 085049749 |
| Company Name | 3D SYSTEMS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816847021142 [Primary] |
| DZJ | Driver, Wire, And Bone Drill, Manual |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
[00816847021142]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2016-09-12 |
| 00816847021463 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021456 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021364 | Reusable accessory Cutting insert |
| 00816847021357 | Reusable accessory Cutting insert |
| 00816847021340 | Reusable accessory Cutting insert |
| 00816847021333 | Reusable accessory Cutting insert |
| 00816847021326 | Reusable accessory drill guide |
| 00816847021319 | Reusable accessory drill guide |
| 00816847021302 | Reusable accessory drill guide |
| 00816847021296 | Reusable accessory drill guide |
| 00816847021289 | A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i |
| 00816847021272 | A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i |
| 00816847021265 | A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i |
| 00816847021210 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021180 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021173 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021142 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021111 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021081 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021050 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847021029 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847020992 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847020961 | A physical template that can be positioned at the osteotomy site that allows the physician the a |
| 00816847020954 | A physical template that can be positioned at the osteotomy site that allows the physician the a |
| 00816847020947 | A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), |
| 00816847020930 | A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), |
| 00816847020763 | A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all |
| 00816847020756 | A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all |
| 00816847020749 | A physical guide used to hold bone in a position dictated by the surgeon for a limited amount of |
| 00816847020725 | A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all |
| 00816847020718 | A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), |
| 00816847020701 | A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), |
| 00816847020695 | A physical template / guide that conforms to patients’ anatomy (Bony and / or Occlusal) to all |
| 00816847020688 | A physical template / guide that is positioned on patients’ anatomy (Bony and / or Occulsal), |