FDA.reportPublic FDA data

MORIA

Primary DI
03700483608348
Brand
MORIA
Company
MORIA SA
Model
M2 SUCTION RING 0
Catalog number
19325/0
Published
2024-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HMYKeratome, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMYKeratome, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483608348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483608348037004836083483700483608348

GMDN Terms#

Term, Definition table
TermDefinition
MicrokeratomeAn electrically-powered ophthalmic surgical instrument intended to be used to create a corneal pocket for the insertion of a corneal implant or to create a flap to prepare the cornea for laser vision correction. It typically consists of a suction ring, an applanator for flattening of the cornea and a mounted blade to create a corneal pocket or a flap. This device is not intended to be used to cut or shave tissue sections from the cornea.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
275937506
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700483628179MORIARADIAL MARKER 8 BLADES20148/82026-07-16
03700483628209MORIARADIAL MARKER 16 BLADES20148/162026-07-16
03700483628261MORIARADIAL MARKER 12 BLADES20148/122026-07-16
03700483600243MORIAEvolution 2-3-3E tubing x10191382023-12-27
03700483630479MORIAGoosey Forceps190902026-04-21
03700483603206MORIAOU LC 250 HEAD ARTIFICIAL CHAMBER19184/2502024-05-07
03700483601974MORIACBSU 50 HEAD - ART. CHAMBER19178/502024-05-07
03700483602032MORIACBSU 130 HEAD - ART. CHAMBER19178/1302024-05-07
03700483602094MORIACBSU 110 HEAD - ART. CHAMBER19178/1102024-05-07
03700483602100MORIACBSU 250 HEAD - ART. CHAMBER19178/2502024-05-07
03700483602124MORIACBSU 300 HEAD - ART. CHAMBER19178/3002024-05-07
03700483603107MORIACBSU 350 HEAD - ART. CHAMBER19178/3502024-05-07
03700483603121MORIAOU LC 110 HEAD ARTIFICIAL CHAMBER19184/1102024-05-07
03700483603145MORIAOU LC 130 HEAD ARTIFICIAL CHAMBER19184/1302024-05-07
03700483603169MORIAOU LC 150 HEAD ARTIFICIAL CHAMBER19184/1502024-05-07
03700483603183MORIAOU LC 200 HEAD ARTIFICIAL CHAMBER19184/2002024-05-07
03700483603220MORIAOU LC 300 HEAD ARTIFICIAL CHAMBER19184/3002024-05-07
03700483603244MORIAOU LC 350 HEAD ARTIFICIAL CHAMBER19184/3502024-05-07
03700483603374MORIAOU LC 400 HEAD ARTIFICIAL CHAMBER19184/4002024-05-07
03700483603398MORIAOU LC 450 HEAD ARTIFICIAL CHAMBER19184/4502024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700483601974MORIAMORIA SAHMY2024-05-07
03700483602032MORIAMORIA SAHMY2024-05-07
03700483602094MORIAMORIA SAHMY2024-05-07
03700483602100MORIAMORIA SAHMY2024-05-07
03700483602124MORIAMORIA SAHMY2024-05-07
03700483603107MORIAMORIA SAHMY2024-05-07
03700483601981MORIAMORIA SAHMY2024-05-07
03700483601998MORIAMORIA SAHMY2024-05-07
03700483602049MORIAMORIA SAHMY2024-05-07
03700483602025MORIAMORIA SAHMY2024-05-07
03700483602117MORIAMORIA SAHMY2024-05-07
03700483602155MORIAMORIA SAHMY2024-05-07
03700483603114MORIAMORIA SAHMY2024-05-07
03700483608270MORIAMORIA SAHMY2024-05-07
03700483608294MORIAMORIA SAHMY2024-05-07
03700483608300MORIAMORIA SAHMY2024-05-07
03700483608331MORIAMORIA SAHMY2024-05-07
03700483608355MORIAMORIA SAHMY2024-05-07
03700483608362MORIAMORIA SAHMY2024-05-07
03700483608379MORIAMORIA SAHMY2024-05-07
03700483608393MORIAMORIA SAHMY2024-05-07
03700483608409MORIAMORIA SAHMY2024-05-07
03700483608478MORIAMORIA SAHMY2024-05-07
03700483608195MORIAMORIA SAHMY2024-05-03
03700483608201MORIAMORIA SAHMY2024-05-03
03700483608218MORIAMORIA SAHMY2024-05-03
03700483608225MORIAMORIA SAHMY2024-05-03
03700483608232MORIAMORIA SAHMY2024-05-03
03700483608188MORIAMORIA SAHMY2024-05-02