| Primary Device ID | 08175700107020 |
| NIH Device Record Key | 2da1e8f3-40f2-4af1-91aa-e2a07dc4e797 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hoffer Optical Zone Marker, With Cross Hairs, 3.5mm, Titanium |
| Version Model Number | AS3-100T-3.5 |
| Catalog Number | AS3-100T-3.5 |
| 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 |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08175700107020 [Primary] |
| HLF | Device, Measuring, Lens Radius, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
[08175700107020]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-22 |
| Device Publish Date | 2022-11-14 |
| 08175700106733 - Mendez Degree Gauge | 2024-07-18 Mendez Degree Gauge, Small Size, 12mm/14mm with 4 slots at 0, 90, 180 and 270 Degrees |
| 08175700106740 - Fixed Caliper | 2024-07-18 Fixed Caliper, 2.0mm-2.5mm, Stainless Steel |
| 08175700106757 - Fixed Caliper | 2024-07-18 Fixed Caliper, 2.0mm-2.5mm, Titanium |
| 08175700106764 - Marker | 2024-07-18 Nujits/Solomon Toric IOL Axis Marker w/5.0mm Optical Zone, For Use with Gimble Mendez Beveled Degree Gauge, Stainless Steel |
| 08175700106771 - Marker | 2024-07-18 Bores Two-Ray Axis Marker, Titanium |
| 08175700107211 - Hoffer Optical Zone Marker | 2024-07-18 Hoffer Optical Zone Marker, With Cross Hairs, 5.5mm, Stainless |
| 08175700157537 - Punches | 2024-07-18 Lewis Lens Loop, Small |
| 08175700157544 - Punches | 2024-07-18 Lewis Lens Loop, Large |