FDA.reportPublic FDA data

ONE

Primary DI
03700483606665
Brand
ONE
Company
MORIA SA
Model
ONE - Punch D7.25mm x1
Catalog number
17200D725
Published
2023-12-27
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
HNJPunch, Corneo-Scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483603299PackageGS11In Commercial Distribution
03700483606665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483603299037004836032993700483603299
03700483606665037004836066653700483606665

GMDN Terms#

Term, Definition table
TermDefinition
Corneal punch setA collection of surgical instruments intended to cut a precise circular section of the cornea (corneal button) from stored cadaveric donor tissue for transplantation into a prepared patient. It typically consists of a small base plate, an extremely sharp and hollow cylinder that has a thin circular cutting edge (a trephine), and a guide through which the trephine can travel. The surgeon typically places a section of corneal tissue into the centre of the base plate (it has a graduated inverse bowl emulating the curvature of the eye), assembles the guide and trephine into position, and applies pressure onto the trephine to cut the button. 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
00757770419807Bausch + LombBausch & Lomb IncorporatedHNJ2026-04-29
00757770500437Bausch + LombBausch & Lomb IncorporatedHNJ2025-08-15
00194613036690MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086510MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086527MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086879MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087005MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087012MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087463MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087555MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613099756MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613100049MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613103453MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108281MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108809MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108816MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109646MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109691MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109707MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110260MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110307MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110390MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110406MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110857MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110994MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111397MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111908MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613123604MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01