| Primary Device ID | 08175700156578 |
| NIH Device Record Key | f4b51742-e539-4cab-86fb-81239ab08cb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Trabeculotome |
| Version Model Number | AS14-205R-T |
| Catalog Number | AS14-205R-T |
| Company DUNS | 968368832 |
| Company Name | AURORA SURGICAL, 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 | 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 | 08175700156578 [Primary] |
| HNJ | Punch, Corneo-Scleral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
[08175700156578]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-14 |
| Device Publish Date | 2024-02-06 |
| 08175700156592 | Mcpherson Trabeculotome, Curved, Angled 8mm Long, Pointed, 3mm Spread, Right |
| 08175700156585 | Mcpherson Trabeculotome, Curved, Angled 8mm Long, Pointed, 3mm Spread, Left |
| 08175700156578 | Harms Trabeculotome, Right, Titanium |
| 08175700156561 | Harms Trabeculotome, Left, Titanium |
| 08175700156554 | Harms Trabeculotome, Right, Stainless Steel |
| 08175700156547 | Harms Trabeculotome, Left, Stainless Steel |