Ophthalmic trocar S9.7100.23

GUDID 53760087123888

A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture the eye to provide access to the interior of the eye for ophthalmic surgery. It is assembled and used together with a compatible cannula, filling its lumen and providing the necessary sharp point, thereby facilitating the introduction of this assembly. The trocar is withdrawn after puncturing, providing a working channel into the interior of the eye. It is typically available for use with an ophthalmic cannulation set. This is a reusable device.

FCI S A S FCI 20 22

Ophthalmic cannula transscleral trocar blade
Primary Device ID53760087123888
NIH Device Record Key1dc87a3a-9422-4623-a20e-77ffdd400657
Commercial Distribution StatusIn Commercial Distribution
Brand NameOphthalmic trocar
Version Model NumberRETILOCK® 23G VALVED SELF-RETAINING TROCAR
Catalog NumberS9.7100.23
Company DUNS763408366
Company NameFCI S A S FCI 20 22
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS103760087123883 [Primary]
GS153760087123888 [Unit of Use]

FDA Product Code

NGYCannula, Trocar, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[53760087123888]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-05
Device Publish Date2020-02-26

On-Brand Devices [Ophthalmic trocar]

53760087123987A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture
53760087123970A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture
53760087123871A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture
53760087123888A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture

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