Identity
- Trade Name
- Trabectome Handpiece FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 550035 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 550035-01 FDA UDI
- Primary DI / UDI-DI
- 00854028002092 FDA UDI
- FDA Product Code
- HQR FDA UDI
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4100 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical handpiece, single-use
Trabectome Handpiece by Neomedix Corp. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Neomedix Corp.
Sources (1)
- FDA UDI 91325025-2fc7-4464-9f75-e8039a1334fe 35 fields · synced May 31, 2026