FDA.reportPublic FDA data

ONE

Primary DI
03700483602582
Brand
ONE
Company
MORIA SA
Model
ONE-TOR.IOL PRE-OP MARK BUBBLE LEVEL
Catalog number
17249X1
Published
2023-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
03700483602582PackageGS11In Commercial Distribution
03700483602186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483602582037004836025823700483602582
03700483602186037004836021863700483602186

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275937506
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03700483603930MORIAOU LC 500 HEAD ARTIFICIAL CHAMBER19184/5002024-05-07
03700483603954MORIAOU LC 550 HEAD ARTIFICIAL CHAMBER19184/5502024-05-07
03700483601981MORIACBSU 50 HEAD - ART. CHAMBER19178/502024-05-07
03700483601998MORIACBSU 90 HEAD - ART. CHAMBER19178/902024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04