Trabectome I/A Cannula

Primary DI
00854028002115
Brand
Trabectome I/A Cannula
Company
NEOMEDIX CORPORATION
Model
550037-01
Device description
"Customized Simcoe Type I/A Cannula with 20mm length straigh tip, 23GA x 23GA, Aspiration through a 13"" flexible tubing via a 0.4mm diameter side port and irrigation through cannula."
Published
2019-07-17
Public version status
Update
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
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854028002115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854028002115008540280021158540280021150854028002115

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-useA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). 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
00854028002108Trabectome Fluidics Set550034-012019-07-17

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