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Trabectome I/A Console (110V)

FDA UDI

Class II (US FDA UDI)

by Neomedix Corp.

Identity

Trade Name
Trabectome I/A Console (110V) FDA UDI
Generic Name
Ophthalmic irrigation/aspiration pump FDA UDI
Device Name
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. FDA UDI
Model / Reference
550014 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
550014-01 FDA UDI
Primary DI / UDI-DI
00854028002023 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Ophthalmic irrigation/aspiration pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ophthalmic irrigation/aspiration pump

Trabectome I/A Console (110V) by Neomedix Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic irrigation/aspiration pump.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neomedix Corp.

Sources (1)

  • FDA UDI 22f4d2dd-06dc-4160-89b5-a8e97f4512d1 35 fields · synced Jun 8, 2026