FDA UDI
In Commercial Distribution
🇺🇸 United States
Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu
DI: 08175700106689
·
Model: AS3-002T
·
AURORA SURGICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titaniu
- Primary DI
- 08175700106689
- Version / Model
- AS3-002T
- Catalog Number
- AS3-002T
- Company Name
- AURORA SURGICAL, LLC
- Labeler DUNS
- 968368832
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-14
- Public Version
- 1
- Public Version Date
- 2022-11-22
- Public Version Status
- New
- Public Device Record Key
- 71a282cf-8b31-4b05-be5c-95c09c9bd4ef
Device Description
Toric IOL Axis Marker w/2.5mm Radial, For Use with Beveled Degree Gauge, Titanium
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HLF | Device, Measuring, Lens Radius, Ophthalmic | Ophthalmic | 886.1430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63521 | Ophthalmic angular gauge, reusable | A non-powered, hand-held, ophthalmic surgical device designed to measure angular distances radially around the surface of the eye [e.g., during intraocular lens (IOL) implantation/alignment]. Also referred to as a Mendez degree gauge, it consists of a handle with a distal ring which includes angle degree markings; it may include blunt teeth on the underside of the ring to allow it to grip to the eye during use. It is not intended for use as a marker. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08175700106689 | GS1 |