FDA.reportPublic FDA data

PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments

Primary DI
08175700110709
Brand
PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments
Company
AURORA SURGICAL, LLC
Model
AS3-629
Catalog number
AS3-629
Device description
Double Ended LASIK Flap Lifter and Spatula (Thorlakson Style)
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLFDevice, Measuring, Lens Radius, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLFDevice, Measuring, Lens Radius, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08175700110709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700110709081757001107098175700110709

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic angular gauge, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7278213303info@aurorasurgical.com

Regulatory Flags#

DUNS number
968368832
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08175700106733Mendez Degree GaugeAS2-0071TAS2-0071T2024-07-10
08175700106740Fixed CaliperAS2-012SAS2-012S2024-07-10
08175700106757Fixed CaliperAS2-012TAS2-012T2024-07-10
08175700106726Gimbel Mendez Beveled Degree Gauge, TitaniumAS2-011TAS2-011T2023-06-23
08175700106504Castroviejo Caliper, Stainless SteelAS2-001SAS2-001S2022-11-14
08175700106511Castroviejo Caliper, TitaniumAS2-001TAS2-001T2022-11-14
08175700106528Osher Internal Incision CaliperAS2-002AS2-0022022-11-14
08175700106535Braunstein Fixed Caliper (3.0mm-3.5mm), Stainless SteelAS2-004SAS2-004S2022-11-14
08175700106542Braunstein Fixed Caliper (3.0mm-3.5mm), TitaniumAS2-004TAS2-004T2022-11-14
08175700106559Braunstein Fixed Caliper (3.5mm-4.0mm), Stainless SteelAS2-005SAS2-005S2022-11-14
08175700106566Braunstein Fixed Caliper (3.5mm-4.0mm), TitaniumAS2-005TAS2-005T2022-11-14
08175700106573Mendez Degree Gauge, Stainless SteelAS2-006SAS2-006S2022-11-14
08175700106580Mendez Degree Gauge, TitaniumAS2-006TAS2-006T2022-11-14
08175700106597Mendez Degree Gauge, Small SizeAS2-007TAS2-007T2022-11-14
08175700106603Grooved Mendez Degree GaugeAS2-008TAS2-008T2022-11-14
08175700106627Internal Micro Incision GaugesAS2-009AS2-0092022-11-14
08175700106634Beveled Mendez Degree Gauge, Stainless SteelAS2-010SAS2-010S2022-11-14
08175700106641Beveled Mendez Degree Gauge, TitaniumAS2-010TAS2-010T2022-11-14
08175700106658Stainless Steel RulerAS2-100AS2-1002022-11-14
08175700106719Helveston Scleral RulerAS2-101AS2-1012022-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223M1113100Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHLF2025-06-20
G22314012520Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHLF2025-04-16
08175700107228Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107235Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107242Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107259Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107266Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107273Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107297Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107396Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107402Bores Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700107419Bores Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700108010Centration MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700108027Centration MarkerAURORA SURGICAL, LLCHLF2024-07-11
08175700109628LRI/Toric MarkersAURORA SURGICAL, LLCHLF2024-07-11
08175700109635LRI/Toric MarkersAURORA SURGICAL, LLCHLF2024-07-11
08175700106764MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700106771MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700107211Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700111607LASIK CannulasAURORA SURGICAL, LLCHLF2024-01-16
05404027410104Sterile,Single Use,Mendez Degree Gauge, form 0To 180,Internal Diameter 12.0mmHasa OptixHLF2023-11-13
05404027424934Sterile,Single Use,Mendez Degree Gauge, form 0To 180,Internal Diameter 12.0mmHasa OptixHLF2023-11-13
08175700107075Hoffer Optical Zone Marker, With Cross Hairs, 4.75mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107099Hoffer Optical Zone Marker, With Cross Hairs, 5.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107105Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107112Hoffer Optical Zone Marker, With Cross Hairs, 6.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107136Hoffer Optical Zone Marker, With Cross Hairs, 7.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107143Hoffer Optical Zone Marker, With Cross Hairs, 8.0mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107150Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107167Hoffer Optical Zone Marker, With Cross Hairs, 9.0mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23