FDA.reportPublic FDA data

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

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
00841668130780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668130780008416681307808416681307800841668130780

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
DM exempt
true
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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