FDA UDI
In Commercial Distribution
🇺🇸 United States
Centration Marker
DI: 08175700108010
·
Model: AS3-301S
·
AURORA SURGICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Centration Marker
- Primary DI
- 08175700108010
- Version / Model
- AS3-301S
- Catalog Number
- AS3-301S
- Company Name
- AURORA SURGICAL, LLC
- Labeler DUNS
- 968368832
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-11
- Public Version
- 1
- Public Version Date
- 2024-07-19
- Public Version Status
- New
- Public Device Record Key
- 6fd8ed8a-8853-4b04-a9ec-73ffc2635789
Device Description
Whipple ll Capsulorrhexis Centration Marker, Marks 5.5mm-6.0mm, Stainless Steel
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 | 08175700108010 | GS1 |
Customer Contacts
- Phone
- 7278213303
- [email protected]