Goniotome Handpiece 550052-15

GUDID 00854028002184

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.

NEOMEDIX CORPORATION

Ophthalmic knife, single-use

• Primary Device ID: 00854028002184
• NIH Device Record Key: fe9c4643-5e00-476c-9a8a-28728cbf5c03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Goniotome Handpiece
• Version Model Number: 550052-15
• Catalog Number: 550052-15
• 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	00854028002184 [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

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