Trabectome Handpiece 550035-01

GUDID 00854028002092

The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic surgery. The handpiece is designed to surgically remove a strip of trabecular meshwork for surgical management of infantile and adult glaucoma. The handpiece is packaged in a surgical procedure pack containing multiple components intended to be utilized in ophthalmic surgery.

NEOMEDIX CORPORATION

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Primary Device ID00854028002092
NIH Device Record Key91325025-2fc7-4464-9f75-e8039a1334fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrabectome Handpiece
Version Model Number550035
Catalog Number550035-01
Company DUNS945496792
Company NameNEOMEDIX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net
Phone714-258-8355
EmailCustomerCare@neomedix.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100854028002092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQRApparatus, Cautery, Radiofrequency, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-16
Device Publish Date2016-09-28

Devices Manufactured by NEOMEDIX CORPORATION

10854028002136 - Trabectome High Frequency Generator (100-240V)2019-12-16 The Trabectome High Frequency Generator (100-240V) is used with compatible electrosurgical instruments for low power microsurgic
10854028002167 - Trabectome I/A Console (100-240V)2019-12-16 The Trabectome I/A Console (100-240V) is an aspiration pump for use in general surgery applications where aspiration of irrigati
00854028002023 - Trabectome I/A Console (110V)2019-12-16 The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irr
00854028002030 - Trabectome High Frequency Generator (110V)2019-12-16 The Trabectome High Frequency Generator (110V) is used with compatible electrosurgical instruments for low power microsurgical a
00854028002092 - Trabectome Handpiece2019-12-16The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic surgery. The handpiece is designed to surgically remove a strip of trabecular meshwork for surgical management of infantile and adult glaucoma. The handpiece is packaged in a surgical procedure pack containing multiple components intended to be utilized in ophthalmic surgery.
00854028002092 - Trabectome Handpiece2019-12-16 The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic sur
00854028002115 - Trabectome I/A Cannula2019-10-07 Customized Simcoe Type I/A Cannula with 20mm length straigh tip, 23GA x 23GA, Aspiration through a 13" flexible tubing via a 0.4
00854028002108 - Trabectome Fluidics Set2019-07-25 Disposable, single use, surgical Irrigation and Aspiration tubing set
00854028002177 - Goniotome +I/A Handpiece2019-07-25 The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plast

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