FDA.report

MALONEY ASIGMATISM KERATOMETER

Primary DI
00841668130780
Brand
MALONEY ASIGMATISM KERATOMETER
Company
KATENA PRODUCTS, INC.
Model
AE-2743
Catalog number
AE-2743
Device description
MALONEY ASIGMATISM KERATOMETER
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HLFDevice, measuring, lens radius, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HLFDevice, Measuring, Lens Radius, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668130780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668130780008416681307808416681307800841668130780

GMDN Terms

TermDefinition
Keratoscope, non-powered, reusableA non-powered, hand-held, ophthalmic instrument intended for qualitative assessment of the curvature of the anterior surface of the cornea, typically to detect astigmatism during ophthalmic surgery (e.g., changes induced by sutures during corneal transplantation). Also referred to as a Maloney keratometer, it is in the form of a hollow cylinder or cone with internal concentric rings designed to be held on the cornea, whereby the distorted reflection of the rings on the corneal surface of the patient is indicative of astigmatism. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags

DUNS number
085668598
Device count
1
DM exempt
true
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841668145906BLINK60-127360-12732026-03-23
00841668145913BLINK60-128060-12802026-03-23
00841668145920BLINK60-128160-12812026-03-23
00841668145937BLINK60-128460-12842026-03-23
00841668145944BLINK60-128560-12852026-03-23
00841668145951BLINK60-159260-15922026-03-23
00841668145968BLINK60-159960-15992026-03-23
00841668145982BLINK60-161060-16102026-03-23
00841668145999BLINK60-161760-16172026-03-23
00841668146002BLINK60-161860-16182026-03-23
00841668146019BLINK60-163060-16302026-03-23
00841668146040BLINK60-163960-16392026-03-23
00841668146057BLINK60-164260-16422026-03-23
00841668146071BLINK60-500460-50042026-03-23
00841668146088BLINK60-500660-50062026-03-23
00841668146095BLINK60-500860-50082026-03-23
00841668146101BLINK60-500960-50092026-03-23
00841668146118BLINK60-502560-50252026-03-23
00841668146125BLINK60-502660-50262026-03-23
00841668146132BLINK60-503060-50302026-03-23

Other Devices Sharing Product Codes

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
08175700107341Bores Optical Zone Marker, 5.75mmAURORA 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