| Primary Device ID | 00081379158837 |
| NIH Device Record Key | 24f3998a-d8fe-40af-932b-24b0eb35b1cb |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | AFFARWLS0 |
| Catalog Number | AFFARWLS0 |
| Company DUNS | 073029645 |
| Company Name | HYHTE HOLDINGS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does n |
| 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 |
| Phone | 7608148047 |
| PARKER@asturamedical.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00081379158837 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00081379158837]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-13 |
| Device Publish Date | 2018-08-13 |
| 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 |