FDA.reportPublic FDA data

Ophthalmic angular gauge, reusable

Definition
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.
GUDID devices
361
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840285320581Walcott Rx ProductsWalcott Rx Product IncRx901-7.52022-12-19
00840285320598Walcott Rx ProductsWalcott Rx Product IncRx901-6.52022-12-19
00840285320604Walcott Rx ProductsWalcott Rx Product IncRx902-7.52022-12-19
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.CK20012026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.CK20022026-04-17
08175700107228Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-6.02024-07-11
08175700107235Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-7.252024-07-11
08175700107242Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-7.52024-07-11
08175700107259Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-7.752024-07-11
08175700107266Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-8.252024-07-11
08175700107273Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-8.52024-07-11
08175700107297Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-9.02024-07-11
08175700107396Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100T-5.752024-07-11
08175700107402Bores Optical Zone MarkerAURORA SURGICAL, LLCAS3-150-3.52024-07-11
08175700107419Bores Optical Zone MarkerAURORA SURGICAL, LLCAS3-150-8.52024-07-11
08175700108010Centration MarkerAURORA SURGICAL, LLCAS3-301S2024-07-11
08175700108027Centration MarkerAURORA SURGICAL, LLCAS3-3002024-07-11
08175700109628LRI/Toric MarkersAURORA SURGICAL, LLCAS3-5102024-07-11
08175700109635LRI/Toric MarkersAURORA SURGICAL, LLCAS3-508-V2024-07-11
08681506801180SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIblades cts2025-12-12
00194613084059MSI Precision Specialty InstrumentsMed Saver, Inc.11-4-07112025-08-01
00194613086541MSI Precision Specialty InstrumentsMed Saver, Inc.11-4-80152025-08-01
00194613086558MSI Precision Specialty InstrumentsMed Saver, Inc.9966EA2025-08-01
00194613086565MSI Precision Specialty InstrumentsMed Saver, Inc.9990EA2025-08-01
00194613086572MSI Precision Specialty InstrumentsMed Saver, Inc.15-2601TAS2025-08-01
00194613087197MSI Precision Specialty InstrumentsMed Saver, Inc.TDK-0-816R-12025-08-01
00194613087487MSI Precision Specialty InstrumentsMed Saver, Inc.OZ029-012025-08-01
00194613087524MSI Precision Specialty InstrumentsMed Saver, Inc.9-705R2025-08-01
00194613099817MSI Precision Specialty InstrumentsMed Saver, Inc.15-3875NAS2025-08-01
00194613101473MSI Precision Specialty InstrumentsMed Saver, Inc.ET-262025-08-01
00194613121372MSI Precision Specialty InstrumentsMed Saver, Inc.ET-01H2025-08-01
00194613121426MSI Precision Specialty InstrumentsMed Saver, Inc.ET-162025-08-01
G223M1113100Medetz Surgical InstrumentsMedetz Surgical Instruments LLCm11-13102025-06-20
G22314012520Medetz Surgical InstrumentsMedetz Surgical Instruments LLC14-0125-22025-04-16
00194613086534MSI Precision Specialty InstrumentsMed Saver, Inc.11-4-80162025-03-21
00194613087265MSI Precision Specialty InstrumentsMed Saver, Inc.5-3532-52025-03-21
08175700106764MarkerAURORA SURGICAL, LLCAS3-003S2024-07-10
08175700106771MarkerAURORA SURGICAL, LLCAS3-004T2024-07-10
08175700107211Hoffer Optical Zone MarkerAURORA SURGICAL, LLCAS3-100S-5.52024-07-10
00840285320734Walcott Rx ProductsWalcott Rx Product IncRx901-5.752024-06-11
08175700111607LASIK CannulasAURORA SURGICAL, LLCAS13-17062024-01-16
00840285320697Walcott Rx ProductsWalcott Rx Product IncRx902-8.52024-01-11
00840285320703Walcott Rx ProductsWalcott Rx Product IncRx902-8.752024-01-11
00883475953848YAMANE Double Needle GuideCHARMANT INC.37-00782023-09-18
00840516131320Anodyne SurgicalPsi/Eye-Ko, Inc.CK10012023-07-21
08175700107075Hoffer Optical Zone Marker, With Cross Hairs, 4.75mm, TitaniumAURORA SURGICAL, LLCAS3-100T-4.752023-06-23
08175700107082Hoffer Optical Zone Marker, With Cross Hairs, 5.0mm, TitaniumAURORA SURGICAL, LLCAS3-100T-5.02023-06-23
08175700107099Hoffer Optical Zone Marker, With Cross Hairs, 5.5mm, TitaniumAURORA SURGICAL, LLCAS3-100T-5.52023-06-23
08175700107105Hoffer Optical Zone Marker, With Cross Hairs, 6.0mm, TitaniumAURORA SURGICAL, LLCAS3-100T-6.02023-06-23
08175700107112Hoffer Optical Zone Marker, With Cross Hairs, 6.5mm, TitaniumAURORA SURGICAL, LLCAS3-100T-6.52023-06-23
08175700107129Hoffer Optical Zone Marker, With Cross Hairs, 7mm, TitaniumAURORA SURGICAL, LLCAS3-100T-7.02023-06-23
08175700107136Hoffer Optical Zone Marker, With Cross Hairs, 7.5mm, TitaniumAURORA SURGICAL, LLCAS3-100T-7.52023-06-23
08175700107143Hoffer Optical Zone Marker, With Cross Hairs, 8.0mm, TitaniumAURORA SURGICAL, LLCAS3-100T-8.02023-06-23
08175700107150Hoffer Optical Zone Marker, With Cross Hairs, 8.5mm, TitaniumAURORA SURGICAL, LLCAS3-100T-8.52023-06-23
08175700107167Hoffer Optical Zone Marker, With Cross Hairs, 9.0mm, TitaniumAURORA SURGICAL, LLCAS3-100T-9.02023-06-23
08175700107174Hoffer Optical Zone Marker, With Cross Hairs, 9.5mm, TitaniumAURORA SURGICAL, LLCAS3-100T-9.52023-06-23
08175700107198Hoffer Optical Zone Marker, With Cross Hairs, 7mm, StainlessAURORA SURGICAL, LLCAS3-100S-7.02023-06-23
08175700107204Hoffer Optical Zone Marker, With Cross Hairs, 8mm, StainlessAURORA SURGICAL, LLCAS3-100S-8.02023-06-23
08175700107303Bores Optical Zone Marker, 4.0mmAURORA SURGICAL, LLCAS3-150-4.02023-06-23
08175700107310Bores Optical Zone Marker, 5.0mmAURORA SURGICAL, LLCAS3-150-5.02023-06-23
08175700107327Bores Optical Zone Marker, 5.5mmAURORA SURGICAL, LLCAS3-150-5.52023-06-23
08175700107334Bores Optical Zone Marker, 5.25mmAURORA SURGICAL, LLCAS3-150-5.252023-06-23
08175700107341Bores Optical Zone Marker, 5.75mmAURORA SURGICAL, LLCAS3-150-5.752023-06-23
08175700107358Bores Optical Zone Marker, 6.0mmAURORA SURGICAL, LLCAS3-150-6.02023-06-23
08175700107365Bores Optical Zone Marker, 7.0mmAURORA SURGICAL, LLCAS3-150-7.02023-06-23
08175700107372Bores Optical Zone Marker, 8.0mmAURORA SURGICAL, LLCAS3-150-8.02023-06-23
08175700107389Bores Optical Zone Marker, 9.0mmAURORA SURGICAL, LLCAS3-150-9.02023-06-23
08175700107501Corneal MarkersAURORA SURGICAL, LLCAS3-200T-42023-06-23
08175700107518Corneal MarkersAURORA SURGICAL, LLCAS3-200T-62023-06-23
08175700107525Corneal MarkersAURORA SURGICAL, LLCAS3-200T-82023-06-23
08175700107532Corneal MarkersAURORA SURGICAL, LLCAS3-200T-102023-06-23
08175700107549Corneal MarkersAURORA SURGICAL, LLCAS3-200T-122023-06-23
08175700107556Corneal MarkersAURORA SURGICAL, LLCAS3-200T-162023-06-23
08175700107754Corneal MarkersAURORA SURGICAL, LLCAS3-200S-42023-06-23
08175700107761Corneal MarkersAURORA SURGICAL, LLCAS3-200S-62023-06-23
08175700107778Corneal MarkersAURORA SURGICAL, LLCAS3-200S-82023-06-23
08175700107785Corneal MarkersAURORA SURGICAL, LLCAS3-200S-102023-06-23
08175700107792Corneal MarkersAURORA SURGICAL, LLCAS3-200S-122023-06-23
08175700107808Corneal MarkersAURORA SURGICAL, LLCAS3-200S-162023-06-23
08175700108003Centration MarkerAURORA SURGICAL, LLCAS3-300S2023-06-23