FDA.reportPublic FDA data

MORIA

Primary DI
03700483608553
Brand
MORIA
Company
MORIA SA
Model
EPI-K LD REUSABLE SUCTION RING -1
Catalog number
19399/-1
Published
2026-07-20
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

Product Codes#

Code, Name table
CodeName
HNOKeratome, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNOKeratome, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483608553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483608553037004836085533700483608553

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
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370048360849MORIAEPI-K REUSABLE SUCTION RING 019389/02026-07-20
03700483600397MORIAM2SU 130 HEAD19334/1302026-07-20
03700483600410MORIAM2SU 90 HEAD19334/902026-07-20
03700483600557MORIAEPI-K SET (-1 RING)193842026-07-20
03700483600571MORIAEpi-K Head193902026-07-20
03700483608416MORIAEPI-K HANDPIECE193422026-07-20
03700483608485MORIAEPI-K REUSABLE SUCTION RING -119389/-12026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00370048360849MORIAMORIA SAHNO2026-07-20
03700483600557MORIAMORIA SAHNO2026-07-20
03700483600571MORIAMORIA SAHNO2026-07-20
03700483608416MORIAMORIA SAHNO2026-07-20
03700483608485MORIAMORIA SAHNO2026-07-20
10810003224757NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224764NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224771NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224788NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224795NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224801NAMICROSPECIALITIES, INC.HNO2026-04-29
10810003224818NAMICROSPECIALITIES, INC.HNO2026-04-29
00380650004529Wave Light FS200 EASYPACKAlcon Laboratories, Inc.HNO2025-11-20
03700483603121MORIAMORIA SAHNO2024-05-07
03700483603145MORIAMORIA SAHNO2024-05-07
03700483603169MORIAMORIA SAHNO2024-05-07
03700483603183MORIAMORIA SAHNO2024-05-07
03700483603206MORIAMORIA SAHNO2024-05-07
03700483603220MORIAMORIA SAHNO2024-05-07
03700483603244MORIAMORIA SAHNO2024-05-07
03700483603374MORIAMORIA SAHNO2024-05-07
03700483603398MORIAMORIA SAHNO2024-05-07
03700483603930MORIAMORIA SAHNO2024-05-07
03700483603954MORIAMORIA SAHNO2024-05-07
03700483603138MORIAMORIA SAHNO2024-05-07
03700483603152MORIAMORIA SAHNO2024-05-07
03700483603176MORIAMORIA SAHNO2024-05-07
03700483603190MORIAMORIA SAHNO2024-05-07
03700483603213MORIAMORIA SAHNO2024-05-07
03700483603237MORIAMORIA SAHNO2024-05-07