| Primary Device ID | 00817906028980 |
| NIH Device Record Key | 7128bb31-6247-4063-94d0-35606cf3cd6c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avenger Radial Head |
| Version Model Number | M07 201A00 |
| Catalog Number | M07 201A00 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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 | false |
| Serial Number | true |
| 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 | 00817906028980 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
[00817906028980]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-13 |
| Device Publish Date | 2024-12-05 |
| 00817906028980 | AVENGER RADIAL HEAD INSTRUMENT TRAY |
| 00817906028973 | Avenger Radial Head System Reamers 7.5 through 9.5, Sterile |
| 00817906028966 | Avenger Radial Head System Awl, 5.6 and 6.5, Planer, Sterile |
| 00817906028959 | Avenger Radial Head System, Trials, Sterile Kit |
| 00810021866406 | Avenger Radial Head Trials, +4mm Stems, Sterile Kit |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AVENGER RADIAL HEAD 88386420 not registered Live/Pending |
In2Bones USA, LLC 2019-04-15 |