| Primary Device ID | 07613327121964 |
| NIH Device Record Key | 009d6f49-0155-4583-b913-5de8a7012322 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UniVise Spinous Process Fixation Plate System |
| Version Model Number | 48590100 |
| Catalog Number | 48590100 |
| Company DUNS | 149183167 |
| Company Name | Stryker Corporation |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 07613327121964 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
[07613327121964]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2019-11-22 |
| 07613327123630 | TRIAL |
| 07613327121957 | TRIAL |
| 07613327121971 | INSERTER INNER SHAFT |
| 07613327121964 | INSERTER |