| Primary Device ID | 00840606169929 |
| NIH Device Record Key | 4d56de43-744a-4f42-b84f-d783826c8cfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KARMA MIS |
| Version Model Number | 75600-000-03 |
| Company DUNS | 610712213 |
| Company Name | SPINAL ELEMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00840606169929 [Primary] |
| OJH | Orthopedic Tray |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
[00840606169929]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-14 |
| Device Publish Date | 2022-02-04 |
| 00840606169974 | Awl Stylet |
| 00840606169936 | Karma® MIS Tray Base |
| 00840606169929 | Karma® MIS Tray Lower Level Insert |
| 00840606169912 | Karma® MIS Tray Top Level Insert |
| 00840606169905 | Karma® MIS Tray Lid |
| 00840606169899 | Karma® MIS Tray Assembly |
| 00840606167956 | Karma Tensioner |