FDA.report

MORIA

Primary DI
03700483606337
Brand
MORIA
Company
MORIA SA
Model
Trephine blade, diameter 7,75 mm
Catalog number
17150D77
Published
2023-12-11
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

Related Records

Product Codes

CodeName
HRHTrephine, Manual, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700483606337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700483606337037004836063373700483606337

GMDN Terms

TermDefinition
Corneal trephine manual instrumentA hand-held, ophthalmic surgical instrument, constructed as a one-piece handle with trephine (not an exchangeable component) that is manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons). The trephine portion consists of a shaft that has at its working end an extremely sharp, bevelled, cylindrical cutting edge. Healthy tissue may be taken from cadavers for transplant to the recipient, where the defect cornea is cut and removed for acceptance of the replacement. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
275937506
Device count
1
DM exempt
true
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
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 DIBrandModelCatalogPublished
03700483601981MORIACBSU 50 HEAD - ART. CHAMBER19178/502024-05-07
03700483601998MORIACBSU 90 HEAD - ART. CHAMBER19178/902024-05-07
03700483602049MORIACBSU 130 HEAD - ART. CHAMBER19178/1302024-05-07
03700483602025MORIACBSU 110 HEAD - ART. CHAMBER19178/1102024-05-07
03700483602117MORIACBSU 250 HEAD - ART. CHAMBER19178/2502024-05-07
03700483602155MORIACBSU 300 HEAD - ART. CHAMBER19178/3002024-05-07
03700483603114MORIACBSU 350 HEAD - ART. CHAMBER19178/3502024-05-07
03700483603138MORIAOU LC 110 HEAD ARTIFICIAL CHAMBER19184/1102024-05-07
03700483603152MORIAOU LC 130 HEAD ARTIFICIAL CHAMBER19184/1302024-05-07
03700483603176MORIAOU LC 150 HEAD ARTIFICIAL CHAMBER19184/1502024-05-07
03700483603190MORIAOU LC 200 HEAD ARTIFICIAL CHAMBER19184/2002024-05-07
03700483603213MORIAOU LC 250 HEAD ARTIFICIAL CHAMBER19184/2502024-05-07
03700483603237MORIAOU LC 300 HEAD ARTIFICIAL CHAMBER19184/3002024-05-07
03700483603251MORIAOU LC 350 HEAD ARTIFICIAL CHAMBER19184/3502024-05-07
03700483603381MORIAOU LC 400 HEAD ARTIFICIAL CHAMBER19184/4002024-05-07
03700483603404MORIAOU LC 450 HEAD ARTIFICIAL CHAMBER19184/4502024-05-07
03700483603947MORIAOU LC 500 HEAD ARTIFICIAL CHAMBER19184/5002024-05-07
03700483603961MORIAOU LC 550 HEAD ARTIFICIAL CHAMBER19184/5502024-05-07
03700483608270MORIALSK C & B MANUAL FIXATION RING -119309/-12024-05-07
03700483608294MORIALSK C & B MANUAL FIXATION RING 119309/12024-05-07

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