Goniotome +I/A Handpiece

GUDID 00854028002177

The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber), irrigation and aspiration tubing extruded from DEHP-free PVC (~15 cm length) terminated with polycarbonate luer connectors. The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel. The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients. The Handpiece can be connected to a suitable ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration of balanced salt solution (BSS) while the procedure is being performed.

NEOMEDIX CORPORATION

Ophthalmic knife, single-use
Primary Device ID00854028002177
NIH Device Record Key21a0b9be-7d60-4494-8c94-e0888eb262d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGoniotome +I/A Handpiece
Version Model Number550052-11
Company DUNS945496792
Company NameNEOMEDIX CORPORATION
Device Count1
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 Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854028002177 [Primary]

FDA Product Code

HNNKnife, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-25
Device Publish Date2019-07-17

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 Handpiece2019-12-16 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 Handpiece2019-07-25The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber), irrigation and aspiration tubing extruded from DEHP-free PVC (~15 cm length) terminated with polycarbonate luer connectors. The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel. The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients. The Handpiece can be connected to a suitable ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration of balanced salt solution (BSS) while the procedure is being performed.
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.