| Primary Device ID | 00860161000376 |
| NIH Device Record Key | 3cd5200d-c88e-4358-8301-d052709d6df1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HXA0005 |
| Version Model Number | HXA0005 |
| Company DUNS | 606309636 |
| Company Name | SURGICAL PLANNING ASSOC 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860161000376 [Primary] |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
[00860161000376]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-03 |
| Device Publish Date | 2022-10-26 |
| 00860161000369 - HipXpert HXA0003B kit | 2023-05-03 |
| 00860161000383 - HX0006 tracker Tray | 2023-05-03 |
| 00860161000352 - Hipxpert HX0002B | 2023-02-16 |
| 00860161000376 - HXA0005 | 2022-11-03 |
| 00860161000376 - HXA0005 | 2022-11-03 |
| 00860161000338 - Hipxpert HX0004 | 2022-10-19 Hipxpert/Insight Lateral kit with tracker tray Instrument System |