| Primary Device ID | 00841379180654 |
| NIH Device Record Key | 05b226ea-fc51-4c45-baf0-e20c07b81594 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | BZ3400020 |
| Catalog Number | BZ3400020 |
| Company DUNS | 073029645 |
| Company Name | HYHTE HOLDINGS, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00841379180654 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
[00841379180654]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-11 |
| Device Publish Date | 2021-08-03 |
| 00840085233319 - NA | 2024-09-11 TRIAL INSERTER |
| 00840085233326 - NA | 2024-09-11 IMPLANT INSERTER |
| 00840085233531 - NA | 2024-09-11 SPACER INSERTER, FORCEPS |
| 00840085242458 - NA | 2024-09-11 FULL PLATE INSERTER |
| 00840085242472 - NA | 2024-09-11 NAIL INSERTION TOOL |
| 00840085268496 - NA | 2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH |
| 00840085268502 - NA | 2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH |
| 00840085268519 - NA | 2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH |