| Primary Device ID | 00816847021425 |
| NIH Device Record Key | 42b8a070-55b8-4e58-af16-cc0abeafd8db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VSP Cranial |
| Version Model Number | Cranial Positioning Guide |
| 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 | 00816847021425 [Primary] |
| PPT | Cranial Surgical Planning And Instrument Guides |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
[00816847021425]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-12 |
| 00816847021449 | A physical template / guide that is positioned on patients’ anatomy (Bony), and allows for pre |
| 00816847021432 | A physical template / guide that is positioned on patients’ anatomy (Bony), and allows for pre |
| 00816847021425 | A physical template / guide that conforms to patients’ anatomy (Bony) to allow manipulation of |