| Primary Device ID | 08175700157551 |
| NIH Device Record Key | 0553b1ee-677b-48fd-8989-8cfffce8b4a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Probes |
| Version Model Number | AS14-400 |
| Catalog Number | AS14-400 |
| 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 | 08175700157551 [Primary] |
| HND | Spatula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700157551]
Moist Heat or Steam Sterilization
[08175700157551]
Moist Heat or Steam Sterilization
[08175700157551]
Moist Heat or Steam Sterilization
[08175700157551]
Moist Heat or Steam Sterilization
[08175700157551]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-18 |
| Device Publish Date | 2024-07-10 |
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| 08175700155625 | Castroviejo Double-Ended Lachrymal Dilator, Size 1 & 2, Stainless Steel |
| 08175700155618 | Wilder Lachrymal Dilator, Size 3, Long Taper, Titanium |
| 08175700155601 | Wilder Lachrymal Dilator, Size 3, Long Taper, Stainless Steel |
| 08175700155595 | Wilder Lachrymal Dilator, Size 2, Medium Taper, Titanium |
| 08175700155588 | Wilder Lachrymal Dilator, Size 2, Medium Taper, Stainless Steel |
| 08175700155571 | Wilder Lachrymal Dilator, Size 1, Short Taper, Titanium |
| 08175700155564 | Wilder Lachrymal Dilator, Size 1, Short Taper, Stainless |
| 08175700155557 | Bowman Lachrymal Probe, Size 7-8 |
| 08175700155540 | Bowman Lachrymal Probe, Size 5-6 |
| 08175700155533 | Bowman Lachrymal Probe, Size 3-4 |
| 08175700155526 | Bowman Lachrymal Probe, Size 1-2 |
| 08175700155519 | Bowman Lachrymal Probe, Size 00-0 |
| 08175700155502 | Bowman Lachrymal Probe, Size 0000-000 |
| 08175700155724 | Bowman Lachrymal Probe, Size 7-8, Titanium |
| 08175700155717 | Bowman Lachrymal Probe, Size 5-6, Titanium |
| 08175700155700 | Bowman Lachrymal Probe, Size 3-4, Titanium |
| 08175700155694 | Bowman Lachrymal Probe, Size 1-2, Titanium |
| 08175700155687 | Bowman Lachrymal Probe, Size 00-0, Titanium |
| 08175700155670 | Bowman Lachrymal Probe, Size 0000-000, Titanium |
| 08175700157551 | Beehler Pupil Dilator, 3 Prong |