| Primary Device ID | 00816847022163 |
| NIH Device Record Key | 70d02f91-e4cb-4440-9d39-72511114a9ed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VSP Orthopedics |
| Version Model Number | Autograft Tibia Cutting 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 | true |
| 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 | 00816847022163 [Primary] |
| PBF | Orthopaedic Surgical Planning And Instrument Guides |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
[00816847022163]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-19 |
| Device Publish Date | 2019-09-11 |
| 00816847022552 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022545 | Reusable accessory drill guide |
| 00816847022538 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022521 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022514 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022507 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022491 | A three dimensional physical model depicting allograft specific modified anatomy. To be used as |
| 00816847022484 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022477 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022460 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022453 | A three dimensional physical model depicting allograft specific modified anatomy. To be used as |
| 00816847022446 | A three dimensional physical model depicting patient specific modified anatomy. To be used as p |
| 00816847022231 | A physical template that is composed of patient's bony anatomy and allows for precise location o |
| 00816847022224 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022217 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022200 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022194 | A physical template that is composed of patient's bony anatomy and allows for precise location o |
| 00816847022187 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022170 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022163 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022156 | A physical template that is composed of patient's bony anatomy and allows for precise location o |
| 00816847022149 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022132 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847022125 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021913 | A physical template that is composed of allograft bony anatomy and allows for precise location o |
| 00816847021906 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021890 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021883 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021876 | A physical template that is composed of allograft bony anatomy and allows for precise location o |
| 00816847021869 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021852 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021845 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021838 | A physical template that is composed of allograft bony anatomy and allows for precise location o |
| 00816847021821 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021814 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021807 | A physical guide that is composed of allograft bony anatomy and allows for precise location of p |
| 00816847021593 | A physical template that is composed of patient's bony anatomy and allows for precise location o |
| 00816847021586 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021579 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021562 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021555 | A physical template that is composed of patient's bony anatomy and allows for precise location o |
| 00816847021548 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021531 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021524 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021517 | A physical template that is composed of patient's bony anatomy and allows for precise location o |
| 00816847021500 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021494 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |
| 00816847021487 | A physical guide that is composed of patient's bony anatomy and allows for precise location of p |