| Primary Device ID | 00810832030980 |
| NIH Device Record Key | 7c43f6cb-3964-4965-87ef-c132758a34ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Harvey Surgical Assistant (HSA) |
| Version Model Number | 405055 |
| Catalog Number | 405055 |
| Company DUNS | 023266163 |
| Company Name | ORTHALIGN, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 | 00810832030980 [Primary] |
| OLO | Orthopedic Stereotaxic Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
[00810832030980]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-24 |
| Device Publish Date | 2020-09-16 |
| 00810832031222 | Harvey Surgical Assistant (HSA) Instrument Set |
| 00810832031130 | Packaged Assembly, Navigation Unit, HSA |
| 00810832030980 | Reference Sensor (RS), HSA |
| 00810832030973 | KA2 Bracket, Nav Unit, HSA |
| 00810832030966 | KA2 Bracket, RS, HSA |