| Primary Device ID | 00846832064953 |
| NIH Device Record Key | dbf1218b-5456-4649-9283-fe1802bee7f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tornier Approach |
| Version Model Number | YRAD1051 |
| Catalog Number | YRAD1051 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, INC. |
| 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 |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com | |
| Phone | +1(888)494-7950 |
| customerservice@tornier.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832064953 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
[00846832064953]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-05 |
| Device Publish Date | 2024-03-28 |
| 00846832065394 | Case Outer Lid |
| 00846832064960 | Lower Tray |
| 00846832064953 | Upper Tray |
| 00846832064748 | Case & Trays |