Trabectome I/A Console (110V) 550014-01

GUDID 00854028002023

The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.

NEOMEDIX CORPORATION

Ophthalmic irrigation/aspiration pump
Primary Device ID00854028002023
NIH Device Record Key22f4d2dd-06dc-4160-89b5-a8e97f4512d1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrabectome I/A Console (110V)
Version Model Number550014
Catalog Number550014-01
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone714-258-8355
EmailCustomerCare@neomedix.net

Device Identifiers

Device Issuing AgencyDevice ID
GS100854028002023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTAPump, Portable, Aspiration (Manual Or Powered)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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)2019-12-16The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.
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 Handpiece2019-12-16 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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