| Primary Device ID | 08175700107006 | 
| NIH Device Record Key | 37032392-421b-4942-bb7d-27987804a45a | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Hoffer Optical Zone Marker, With Cross Hairs, 3mm, Titanium | 
| Version Model Number | AS3-100T-3.0 | 
| Catalog Number | AS3-100T-3.0 | 
| 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 | 08175700107006 [Primary] | 
| HLF | Device, Measuring, Lens Radius, Ophthalmic | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
Moist Heat or Steam Sterilization
[08175700107006]
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 | 
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| 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 |