| Primary Device ID | 00840085214424 |
| NIH Device Record Key | 706449a4-948e-47ac-beac-cd55b4b7ffca |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | KZA040000 |
| Catalog Number | KZA040000 |
| 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 |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Angle | 90 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840085214424 [Primary] |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
Moist Heat or Steam Sterilization
[00840085214424]
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 |
| 00840085271861 - NA | 2025-03-06 EGPS, LUMBAR PEDICLE AWL |
| 00840085271878 - NA | 2025-03-06 EGPS, LUMBAR PEDICLE PROBE, STRAIGHT |
| 00840085271885 - NA | 2025-03-06 EGPS, LUMBAR PEDICLE PROBE, CURVED |
| 00840085271892 - NA | 2025-03-06 EGPS, THORACIC PEDICLE PROBE, STRAIGHT |
| 00840085271908 - NA | 2025-03-06 EGPS, THORACIC PEDICLE PROBE, CURVED |
| 00840085271915 - NA | 2025-03-06 EGPS, REAMING PILOT DRILL, 3.5MM |
| 00840085271922 - NA | 2025-03-06 EGPS, CORTICAL, TAP, 3.5MM |
| 00840085271939 - NA | 2025-03-06 EGPS, CORTICAL, TAP, 4.0MM |