neomedix.netTRABECTOME HIGH FREQUENCY GENERATOR/LP
NEOMEDIX CORP.
NEOMEDIX CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2032569 | 3003698071 | NEOMEDIX CORPORATION | 1 | N | 2020-04-25 | 15042 Parkway Loop Suite A TUSTIN CA US 92780 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00854028002023 | Trabectome I/A Console (110V) - 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. | 714-258-8355 | CustomerCare@neomedix.net |
| 00854028002030 | Trabectome High Frequency Generator (110V) - The Trabectome High Frequency Generator (110V) is used with compatible electrosurgical instruments for low power microsurgical applications for the removal, destruction and coagulation of tissue. | 714-258-8355 | info@neomedix.net |
| 00854028002092 | Trabectome Handpiece - 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. | 714-258-8355 | CustomerCare@neomedix.net |
| 10854028002136 | Trabectome High Frequency Generator (100-240V) - The Trabectome High Frequency Generator (100-240V) is used with compatible electrosurgical instruments for low power microsurgical applications for the removal, destruction and coagulation of tissue. | 714-258-8355 | CustomerCare@neomedix.net |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 60481 | 1190579028 | K061258 | TRABECTOME HIGH FREQUENCY GENERATOR/LP | GEI | 2006-05-18 |
| 60481 | 1584533065 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | 2005-05-17 |
| 60481 | 1138086257 | K040584 | NMX-1000 | GEI | 2004-04-22 |
| 60481 | 1606901989 | K040239 | SUPRAFLOW CONSOLE | BTA | 2004-02-17 |
| 60481 | 1036042148 | ||||
| 60481 | 1694880447 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Goniotome Handpiece - 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), and a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber). 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.
2019-07-17
Goniotome +I/A Handpiece - 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.
2019-07-17
Trabectome Handpiece - 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.
2016-09-28
Trabectome High Frequency Generator (110V) - The Trabectome High Frequency Generator (110V) is used with compatible electrosurgical instruments for low power microsurgical applications for the removal, destruction and coagulation of tissue.
2016-09-28
Trabectome High Frequency Generator (100-240V) - The Trabectome High Frequency Generator (100-240V) is used with compatible electrosurgical instruments for low power microsurgical applications for the removal, destruction and coagulation of tissue.
2016-09-28
Trabectome I/A Console (110V) - 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.
2016-09-28
Trabectome I/A Console (100-240V) - The Trabectome I/A Console (100-240V) is an aspiration pump for use in general surgery applications where aspiration of irrigation and waste fluids from a surgical site is desired,
2016-09-28
Trabectome I/A Cannula - "Customized Simcoe Type I/A Cannula with 20mm length straigh tip, 23GA x 23GA, Aspiration through a 13"" flexible tubing via a 0.4mm diameter side port and irrigation through cannula."
2019-07-17
Trabectome Fluidics Set - Disposable, single use, surgical Irrigation and Aspiration tubing set
2019-07-17