FDA.reportPublic FDA data

Millennium

Primary DI
00190776360092
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
86-420
Device description
McIntyre Binkhorst Cannula, I-A,
Published
2023-02-22
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
HMXCannula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776360092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776360092001907763600921907763600920190776360092

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA 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. 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 reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776433017Millennium1-3201222026-10-01
00190776433024Millennium1-5255712026-10-01
00190776433031Millennium72-52832404M2026-10-01
00190776433048Millennium1-3201042026-10-01
00190776433055Millennium1-7752SD2026-10-01
00190776433062Millennium72-31940512026-10-01
00190776433079Millennium72-317910012026-10-01
00190776433086Millennium72-180526NR2026-10-01
00190776433093Millennium72-4220812026-10-01
00190776433109Millennium1-3202132026-10-01
00190776433116Millennium1-2051362026-10-01
00190776433123Millennium72-23011WS2026-10-01
00190776433130Millennium72-2411004CM2026-10-01
00190776433147Millennium72-2411003CM2026-10-01
00190776433154Millennium72-5242002H2026-10-01
00190776433161Millennium72-5242003H2026-10-01
00190776433178Millennium72-2414002026-10-01
00190776433185Millennium92-H0498R2026-10-01
00190776432911Millennium72-2430130452026-09-30
00190776432928Millennium72-5225522B42026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432966MillenniumAvalign Technologies, Inc.HMX2026-09-30
00190776428228MillenniumAvalign Technologies, Inc.HMX2026-08-27
00840285320802Walcott Rx productsWalcott Rx Product IncHMX2026-08-18
00190776425821MillenniumAvalign Technologies, Inc.HMX2026-08-17
00840319759271Hayden MedicalHayden Medical, Inc.HMX2026-08-14
G223140475250Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-08-03
B382S34701200Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347061000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S34745150Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347671000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891190Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347911020Surgical DirectSurgical Direct, Inc.HMX2026-07-31
G223140190270Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-07-27
00190776403843MillenniumAvalign Technologies, Inc.HMX2026-07-21
00190776400569MillenniumAvalign Technologies, Inc.HMX2026-07-19
00860015282040Intrace USAPILOTIS TECH LLCHMX2026-07-03
00840285320796Walcott Rx ProductsWalcott Rx Product IncHMX2026-06-26
00840319759189Hayden MedicalHayden Medical, Inc.HMX2026-06-24
04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903175Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903632Chang Phaco ChopperA1 Medical GmbHHMX2026-06-09
04251047903755Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047915086Akahoshi Combo Pre-ChopperA1 Medical GmbHHMX2026-05-29
04251047923296Rycroft Air Injection CannulaA1 Medical GmbHHMX2026-05-29
04251047923388Sauter Hydrodissection CannulaA1 Medical GmbHHMX2026-05-29
04251047933295Gerten Clear Cornea DALK CannulaA1 Medical GmbHHMX2026-05-29
04251047934520Gerten Easy Liquid Bubble DMEK CannulaA1 Medical GmbHHMX2026-05-29
08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09