Identity
- Trade Name
- Goniotome +I/A Handpiece FDA UDI
- Generic Name
- Ophthalmic knife, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 550052-11 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854028002177 FDA UDI
- FDA Product Code
- HNN FDA UDI
- GMDN Term
- Ophthalmic knife, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic knife, single-use
Goniotome +I/A Handpiece by Neomedix Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Neomedix Corp.
Sources (1)
- FDA UDI 21a0b9be-7d60-4494-8c94-e0888eb262d3 33 fields · synced May 30, 2026