| Primary Device ID | 00841379106005 |
| NIH Device Record Key | 219c6ad3-60ab-42aa-b77c-f6b6e5535cfd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DZ0400000 |
| Catalog Number | DZ0400000 |
| 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 | false |
| 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 |
| Phone | 7608148047 |
| TROY@ASTURAMEDICAL.COM |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841379106005 [Primary] |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841379106005]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-09 |
| 00840085254413 - NA | 2024-05-07 POLYAXIAL, TULIP |
| 00840085254420 - NA | 2024-05-07 POLYAXIAL, HIGH TOP, TULIP |
| 00840085254437 - NA | 2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP |
| 00840085254444 - NA | 2024-05-07 FAVORED ANGLE M/L, TULIP |
| 00840085254451 - NA | 2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP |
| 00840085254468 - NA | 2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP |
| 00840085254475 - NA | 2024-05-07 FAVORED ANGLE C/C, TULIP |
| 00840085254482 - NA | 2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP |