| Primary Device ID | 00816847022583 |
| NIH Device Record Key | 6dbc6a05-9e51-4b78-8a60-f0905026ad02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vantage PSI |
| Version Model Number | Tibia Cutting Guide |
| Catalog Number | 351-80-10 |
| 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 | false |
| 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 |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Length | 25 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816847022583 [Primary] |
| OYK | Ankle Arthroplasty Implantation System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
[00816847022583]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-08-15 |
| Device Publish Date | 2020-11-13 |
| 00816847022590 | A three dimensional physical model depicting patient specific anatomy. To be used as pre- and i |
| 00816847022583 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022606 | Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cut |
| 00816847022576 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |