FDA.reportPublic FDA data

MORIA

Primary DI
03700483604104
Brand
MORIA
Company
MORIA SA
Model
Wolkmann Retractor with 4 prongs
Catalog number
1353
Published
2023-12-14
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
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700483604104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700483604104037004836041043700483604104

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
275937506
Device count
1
DM exempt
true
Premarket 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
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

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