FDA.reportPublic FDA data

Trabectome I/A Console (100-240V)

Primary DI
10854028002167
Brand
Trabectome I/A Console (100-240V)
Company
NEOMEDIX CORPORATION
Model
550014-02
Catalog number
550014-02
Device description
The Trabectome I/A Console (100-240V) is an aspiration pump for use in general surgery applications where aspiration of irrigation and waste fluids from a surgical site is desired,
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854028002167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085402800216710854028002167

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/aspiration pumpA mains electricity (AC-powered), ophthalmic device used to irrigate the area pertaining to the eye and eye cavity with a fluid to provide a flushing effect during ophthalmic surgery and also to aspirate by drawing liquid out of the pertinent area. It will be used for the removal of, e.g., debris, tissue or fluids from the site, and will assist the operator by keeping the site cleared and improving the field of observation. It is commonly used during cataract operations and can generate a positive and/or negative pressure with its pumping systems and is used together with compatible instruments. This device must operate at extremely low pressure to avoid inadvertent damage to the site.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-258-8355CustomerCare@neomedix.net

Regulatory Flags#

DUNS number
945496792
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854028002177Goniotome +I/A Handpiece550052-112019-07-17
00854028002184Goniotome Handpiece550052-15550052-152019-07-17
10854028002136Trabectome High Frequency Generator (100-240V)550050550050-012016-09-28
00854028002030Trabectome High Frequency Generator (110V)550047550047-012016-09-28
00854028002092Trabectome Handpiece550035550035-012016-09-28
00854028002023Trabectome I/A Console (110V)550014550014-012016-09-28
00854028002115Trabectome I/A Cannula550037-012019-07-17
00854028002108Trabectome Fluidics Set550034-012019-07-17

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Primary DI, Brand, Company table
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00810149098222R&D Batteries, Inc.R & D Batteries, Inc.BTA2026-01-20
00860014862700GROWNSYOak Tech LLCBTA2026-01-10
00860014862717GROWNSYOak Tech LLCBTA2026-01-10
00860014862724GROWNSYOak Tech LLCBTA2026-01-10
06973222511606Electric Nasal AspiratorShenzhen Desida Technology Co., Ltd.BTA2025-12-31
00810149098178R&D Batteries, Inc.R & D Batteries, Inc.BTA2025-10-27
00860014577550HEYVALUEOak Tech LLCBTA2025-10-13
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06953775661706BBLOVEAlicn Medical Shenzhen, Inc.BTA2025-08-04
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