| Primary Device ID | 00840606184700 |
| NIH Device Record Key | ab8dfabc-3ceb-420b-aa1f-63f78c055e3a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crystal |
| Version Model Number | 20057-001 |
| Company DUNS | 610712213 |
| Company Name | SPINAL ELEMENTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 00840606184700 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
[00840606184700]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-11 |
| Device Publish Date | 2024-06-03 |
| 00840606153331 | 14MM X 11MM X 6MM 7° TRIAL/RASP 1:1 |
| 00840606153324 | 14MM X 11MM X 5MM 7° TRIAL/RASP 1:1 |
| 00840606153317 | 16MM X 13MM X 12MM 7° TRIAL/RASP 1:1 |
| 00840606153300 | 16MM X 13MM X 11MM 7° TRIAL/RASP 1:1 |
| 00840606153294 | 16MM X 13MM X 10MM 7° TRIAL/RASP 1:1 |
| 00840606153287 | 16MM X 13MM X 9MM 7° TRIAL/RASP 1:1 |
| 00840606153270 | 16MM X 13MM X 8MM 7° TRIAL/RASP 1:1 |
| 00840606153263 | 16MM X 13MM X 7MM 7° TRIAL/RASP 1:1 |
| 00840606153256 | 16MM X 13MM X 6MM 7° TRIAL/RASP 1:1 |
| 00840606153249 | 16MM X 13MM X 5MM 7° TRIAL/RASP 1:1 |
| 00840606153522 | 14MM X 11MM X 9MM 0° TRIAL/RASP 1:1 |
| 00840606153515 | 14MM X 11MM X 8MM 0° TRIAL/RASP 1:1 |
| 00840606153508 | 14MM X 11MM X 7MM 0° TRIAL/RASP 1:1 |
| 00840606153492 | 14MM X 11MM X 6MM 0° TRIAL/RASP 1:1 |
| 00840606153485 | 14MM X 11MM X 5MM 0° TRIAL/RASP 1:1 |
| 00840606153478 | 16MM X 13MM X 12MM 0° TRIAL/RASP 1:1 |
| 00840606153461 | 16MM X 13MM X 11MM 0° TRIAL/RASP 1:1 |
| 00840606153454 | 16MM X 13MM X 10MM 0° TRIAL/RASP 1:1 |
| 00840606153447 | 16MM X 13MM X 9MM 0° TRIAL/RASP 1:1 |
| 00840606153430 | 16MM X 13MM X 8MM 0° TRIAL/RASP 1:1 |
| 00840606153423 | 16MM X 13MM X 7MM 0° TRIAL/RASP 1:1 |
| 00840606153416 | 16MM X 13MM X 6MM 0° TRIAL/RASP 1:1 |
| 00840606153409 | 16MM X 13MM X 5MM 0° TRIAL/RASP 1:1 |
| 00840606153393 | 14MM X 11MM X 12MM 7° TRIAL/RASP 1:1 |
| 00840606153386 | 14MM X 11MM X 11MM 7° TRIAL/RASP 1:1 |
| 00840606153379 | 14MM X 11MM X 10MM 7° TRIAL/RASP 1:1 |
| 00840606153362 | 14MM X 11MM X 9MM 7° TRIAL/RASP 1:1 |
| 00840606153355 | 14MM X 11MM X 8MM 7° TRIAL/RASP 1:1 |
| 00840606153348 | 14MM X 11MM X 7MM 7° TRIAL/RASP 1:1 |
| 00840606153676 | 14MM X 11MM X 8MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153669 | 14MM X 11MM X 7MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153652 | 14MM X 11MM X 6MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153645 | 14MM X 11MM X 5MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153638 | 16MM X 13MM X 12MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153621 | 16MM X 13MM X 11MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153614 | 16MM X 13MM X 10MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153607 | 16MM X 13MM X 9MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153591 | 16MM X 13MM X 8MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153584 | 16MM X 13MM X 7MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153577 | 16MM X 13MM X 6MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153560 | 16MM X 13MM X 5MM 7° TRIAL/RASP 1:1 NO STOP |
| 00840606153553 | 14MM X 11MM X 12MM 0° TRIAL/RASP 1:1 |
| 00840606153546 | 14MM X 11MM X 11MM 0° TRIAL/RASP 1:1 |
| 00840606153539 | 14MM X 11MM X 10MM 0° TRIAL/RASP 1:1 |
| 00840606153935 | 14MM X 11MM X 7MM/8MM 0° DUAL TRIAL 1:1 |
| 00840606153928 | 14MM X 11MM X 5MM/6MM 0° DUAL TRIAL 1:1 |
| 00840606153911 | 14MM X 11MM X 11MM/12MM 7° DUAL TRIAL 1:1 |
| 00840606153904 | 14MM X 11MM X 9MM/10MM 7° DUAL TRIAL 1:1 |
| 00840606153898 | 14MM X 11MM X 7MM/8MM 7° DUAL TRIAL 1:1 |
| 00840606153881 | 14MM X 11MM X 5MM/6MM 7° DUAL TRIAL 1:1 |