| Primary Device ID | 00840097502090 |
| NIH Device Record Key | 63d26201-35d2-4030-8039-c49fb45ea207 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | restor3d Reusable Trial |
| Version Model Number | 5000-0301 |
| Company DUNS | 080819836 |
| Company Name | Restor3d |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840097502090 [Primary] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
[00840097502090]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-24 |
| Device Publish Date | 2019-12-16 |
| 00840097502137 | Reusable Trial, Cotton Wedge, Medium Footprint |
| 00840097502120 | Reusable Trial, Cotton Wedge, Small Footprint |
| 00840097502113 | Reusable Trial, Evans Wedge, Large Footprint |
| 00840097502106 | Reusable Trial, Evans Wedge, Medium Footprint |
| 00840097502090 | Reusable Trial, Evans Wedge, Small Footprint |