FDA.reportPublic FDA data

Trabectome Fluidics Set

Primary DI
00854028002108
Brand
Trabectome Fluidics Set
Company
NEOMEDIX CORPORATION
Model
550034-01
Device description
Disposable, single use, surgical Irrigation and Aspiration tubing set
Published
2019-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KYGDevice, Irrigation, Ocular Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYGDevice, Irrigation, Ocular SurgeryOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854028002108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854028002108008540280021088540280021080854028002108

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration tubing setA collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
945496792
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
10854028002167Trabectome I/A Console (100-240V)550014-02550014-022016-09-28
00854028002023Trabectome I/A Console (110V)550014550014-012016-09-28
00854028002115Trabectome I/A Cannula550037-012019-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770636105Bausch + LombBausch & Lomb IncorporatedKYG2026-04-30
B090MT2020MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
B090MT2021MorTanZIEN MEDICAL TECHNOLOGIES, INC.KYG2026-02-10
G22312647930Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2025-11-05
00757770636266Bausch + LombBausch & Lomb IncorporatedKYG2025-08-05
00757770483402Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
00757770492329Bausch + LombBausch & Lomb IncorporatedKYG2025-07-29
B090MT20000MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT20001MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
B090MT66730MorTan ZIEN MEDICAL TECHNOLOGIES, INC.KYG2025-06-25
08052276027290Dual Bore Cannula 23G, 36mmAKTIVE SRLKYG2025-06-04
00757770406463Bausch + LombBausch & Lomb IncorporatedKYG2024-11-21
00194613022938MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613022945MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023959MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613023973MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044817MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613044824MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613046101MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060091MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613060633MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613088057MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
00194613090340MSI Precision Specialty InstrumentsMed Saver, Inc.KYG2024-08-15
G223IAT3S45Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-06-17
G223IAT3S450Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKYG2024-05-23
08052276026354Set Bi-manual I/A Handpieces 23GAKTIVE SRLKYG2024-01-11
08052276026361Set Bi-Manual I/A Handpieces 21GAKTIVE SRLKYG2024-01-11
08052276026378Passive Reservoir AKTIVE SRLKYG2024-01-11
08052276026385Active ReservoirAKTIVE SRLKYG2024-01-11
08052276027450Dual Bore Cannula 27GAKTIVE SRLKYG2024-01-11