Counter Torque
GUDID 07290115932706
PREMIA SPINE LTD
Orthopaedic counter-torque/rod-pushing instrument| Primary Device ID | 07290115932706 |
| NIH Device Record Key | 40775bc5-2ba4-48cc-8fb6-fa1386c6ab38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Counter Torque |
| Version Model Number | 83142 |
| Company DUNS | 649220779 |
| Company Name | PREMIA SPINE LTD |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290115932706 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
| QWK | Prosthesis, Posterior Spinal Elements |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
[07290115932706]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-11 |
| Device Publish Date | 2024-09-03 |
Devices Manufactured by PREMIA SPINE LTD
| 07290115935264 - PER System 60 | 2024-10-18 PER System 60 |
| 07290115935271 - PER System 75 | 2024-10-18 PER System 75 |
| 07290115935332 - PER System 50 | 2024-10-18 PER System 50 |
| 07290115935561 - Distractor | 2024-10-18 |
| 07290115931808 - Ring Nut Inserter | 2024-10-09 |
| 07290115932485 - Ring Nut Loading Base | 2024-10-09 |
| 07290115932515 - Versalink Nut Counter Torque | 2024-10-09 |
| 07290115932553 - VersaLink Bender | 2024-10-09 |
Trademark Results [Counter Torque]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COUNTER TORQUE 75923661 2535609 Dead/Cancelled |
NMTC, INC. 2000-02-22 |
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