FDA.reportPublic FDA data

Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, Titanium

Primary DI
08175700107105
Brand
Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, Titanium
Company
AURORA SURGICAL, LLC
Model
AS3-100T-6.0
Catalog number
AS3-100T-6.0
Device description
Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, Titanium
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
08175700107105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700107105081757001071058175700107105

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
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
08175700107174Hoffer Optical Zone Marker, With Cross Hairs, 9.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23