Device Description : The Trabectome I/A Console (110V) is an aspiration pump intended for use in gene 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.
Device Class : 2
Duns Number: 945496792
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Trabectome High Frequency Generator (110V) is used with compatible electrosu 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.
Device Class : 2
Duns Number: 945496792
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Trabectome Handpiece is intended to be used in electrosurgical applications 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.
Device Class : 2
Duns Number: 945496792
Premarket Exempt : No
Prescription Use : Yes
Device Description : Disposable, single use, surgical Irrigation and Aspiration tubing set
Device Class : 1
Duns Number: 945496792
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Customized Simcoe Type I/A Cannula with 20mm length straigh tip, 23GA x 23GA, As 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.
Device Class : 1
Duns Number: 945496792
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil- 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.
Device Class : 1
Duns Number: 945496792
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil- 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.
Device Class : 1
Duns Number: 945496792
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The Trabectome High Frequency Generator (100-240V) is used with compatible elect 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.
Device Class : 2
Duns Number: 945496792
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Trabectome I/A Console (100-240V) is an aspiration pump for use in general s 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,
Device Class : 2
Duns Number: 945496792
Premarket Exempt : No
Prescription Use : Yes