FDA.report

MORIA

Primary DI
03700483607983
Brand
MORIA
Company
MORIA SA
Model
Troutman-O'Brien Needle Holder, curved, without lo
Catalog number
TI9960
Published
2023-12-17
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
HNMNeedle, Ophthalmic Suturing

Product Code Classifications

CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700483607983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700483607983037004836079833700483607983

GMDN Terms

TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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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