FDA.reportPublic FDA data

Bores Optical Zone Marker, 5.75mm

Primary DI
08175700107341
Brand
Bores Optical Zone Marker, 5.75mm
Company
AURORA SURGICAL, LLC
Model
AS3-150-5.75
Catalog number
AS3-150-5.75
Device description
Bores Optical Zone Marker, 5.75mm
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08175700107341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700107341081757001073418175700107341

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
08175700106764MarkerAS3-003SAS3-003S2024-07-10
08175700106771MarkerAS3-004TAS3-004T2024-07-10
08175700107211Hoffer Optical Zone MarkerAS3-100S-5.5AS3-100S-5.52024-07-10
08175700157537PunchesAS14-308AS14-3082024-07-10
08175700157544PunchesAS14-309AS14-3092024-07-10
08175700157551ProbesAS14-400AS14-4002024-07-10
08175700157001PunchesAS14-300AS14-3002024-03-11
08175700157018PunchesAS14-301AS14-3012024-03-11
08175700157025PunchesAS14-302AS14-3022024-03-11
08175700157032PunchesAS14-303AS14-3032024-03-11
08175700157049PunchesAS14-304AS14-3042024-03-11
08175700157506PunchesAS14-305AS14-3052024-03-11
08175700157513PunchesAS14-306AS14-3062024-03-11
08175700157520PunchesAS14-307AS14-3072024-03-11
08175700155670ProbesAS14-001TAS14-001T2024-02-06
08175700155687ProbesAS14-002TAS14-002T2024-02-06
08175700155694ProbesAS14-003TAS14-003T2024-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223M1113100Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHLF2025-06-20
08175700106764MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700106771MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700107211Hoffer Optical Zone MarkerAURORA SURGICAL, LLCHLF2024-07-10
08175700111607LASIK CannulasAURORA SURGICAL, LLCHLF2024-01-16
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
08175700107174Hoffer Optical Zone Marker, With Cross Hairs, 9.5mm, TitaniumAURORA SURGICAL, LLCHLF2023-06-23
08175700107198Hoffer Optical Zone Marker, With Cross Hairs, 7mm, StainlessAURORA SURGICAL, LLCHLF2023-06-23
08175700107204Hoffer Optical Zone Marker, With Cross Hairs, 8mm, StainlessAURORA SURGICAL, LLCHLF2023-06-23
08175700107310Bores Optical Zone Marker, 5.0mmAURORA SURGICAL, LLCHLF2023-06-23
08175700107334Bores Optical Zone Marker, 5.25mmAURORA SURGICAL, LLCHLF2023-06-23
08175700107358Bores Optical Zone Marker, 6.0mmAURORA SURGICAL, LLCHLF2023-06-23
08175700107365Bores Optical Zone Marker, 7.0mmAURORA SURGICAL, LLCHLF2023-06-23
08175700107372Bores Optical Zone Marker, 8.0mmAURORA SURGICAL, LLCHLF2023-06-23
08175700107389Bores Optical Zone Marker, 9.0mmAURORA SURGICAL, LLCHLF2023-06-23
08175700107501Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23
08175700107518Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23
08175700107525Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23
08175700107532Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23
08175700107549Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23
08175700107556Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23
08175700107754Corneal MarkersAURORA SURGICAL, LLCHLF2023-06-23