FDA.reportPublic FDA data

ONE

Primary DI
03700483612413
Brand
ONE
Company
MORIA SA
Model
ONE S- Corneal marker diameter 9mm X5
Catalog number
17520X5
Published
2023-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483622740PackageGS15In Commercial Distribution
03700483612413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483622740037004836227403700483622740
03700483612413037004836124133700483612413

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, single-useA manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.

Regulatory Flags#

DUNS number
275937506
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
03700483628179MORIAMORIA SAHMR2026-07-16
03700483628209MORIAMORIA SAHMR2026-07-16
03700483628261MORIAMORIA SAHMR2026-07-16
04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
00757770714643Bausch + LombBausch & Lomb IncorporatedHMR2026-05-11
00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420482MillenniumAvalign Technologies, Inc.HMR2026-04-16
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144305KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144312KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144329KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144336KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144343KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144367KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144374KatenaKATENA PRODUCTS, INC.HMR2026-03-31
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05