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 Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use Ophthalmic knife, single-use

• Primary Device ID: 00854028002177
• NIH Device Record Key: 21a0b9be-7d60-4494-8c94-e0888eb262d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Goniotome +I/A Handpiece
• Version Model Number: 550052-11
• Company DUNS: 945496792
• Company Name: NEOMEDIX CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854028002177 [Primary]

FDA Product Code

• HNN: Knife, Ophthalmic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-25
• Device Publish Date: 2019-07-17

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 Handpiece: 2019-12-16 The Trabectome Handpiece is intended to be used in electrosurgical applications in soft tissue, in general and in ophthalmic sur
• 00854028002115 - Trabectome I/A Cannula: 2019-10-07 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 Set: 2019-07-25 Disposable, single use, surgical Irrigation and Aspiration tubing set
• 00854028002177 - Goniotome +I/A Handpiece: 2019-07-25The 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 Handpiece: 2019-07-25 The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plast