FDA.reportPublic FDA data

MANDEL KERATOMETER

Primary DI
00841668130803
Brand
MANDEL KERATOMETER
Company
KATENA PRODUCTS, INC.
Model
AE-2744
Catalog number
AE-2744
Device description
MANDEL 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

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
00841668130803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668130803008416681308038416681308030841668130803

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags#

DUNS number
085668598
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

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Primary DI, Brand, Company table
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G22314012520Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHLF2025-04-16
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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
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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
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
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