FDA.reportPublic FDA data

Hoffer Optical Zone Marker, With Cross Hairs, 5.0mm, Titanium

Primary DI
08175700107082
Brand
Hoffer Optical Zone Marker, With Cross Hairs, 5.0mm, Titanium
Company
AURORA SURGICAL, LLC
Model
AS3-100T-5.0
Catalog number
AS3-100T-5.0
Device description
Hoffer Optical Zone Marker, With Cross Hairs, 5.0mm, 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
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08175700107082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08175700107082081757001070828175700107082

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
04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
00757770714643Bausch + LombBausch & Lomb IncorporatedHMR2026-05-11
00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144305KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144312KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144329KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144336KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144343KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144367KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144374KatenaKATENA PRODUCTS, INC.HMR2026-03-31
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04