FDA.reportPublic FDA data

Hayden Medical

Primary DI
00840319759189
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
E7-2134
Catalog number
E7-2134
Device description
McIntyre Inner Cannula 23ga, straight shaft, .25mm side port, 46mm overall length
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00840319759189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319759189008403197591898403197591890840319759189

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(661)296-7200info@haydenmedical.com

Regulatory Flags#

DUNS number
618214410
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840319759271Hayden MedicalE7-2157E7-21572026-08-14
00840319759202Hayden MedicalE5-6408E5-64082026-07-30
00840319759035Hayden MedicalPWT1064PWT10642026-06-10
00840319759042Hayden MedicalH-1004H-10042026-06-04
00840319759059Hayden MedicalH-1004H-10042026-06-04
00840319759066Hayden MedicalH-20012026-06-04
00840319759073Hayden MedicalH-1002H-10022026-06-04
00840319759028Hayden MedicalE5-6459E5-64592026-05-15
00840319759004Hayden MedicalE7-2385E7-23852026-05-13
00840319759011Hayden Medical405-450S405-450S2026-05-01
00840319757987Hayden Medical405-463CS405-463CS2026-04-23
00840319758977Hayden Medical405-466CS405-466CS2026-04-23
00840319758984Hayden Medical405-470405-4702026-04-22
00840319758991Hayden Medical405-465CS405-465CS2026-04-22
00840319757994Hayden Medical405-465CS405-465CS2025-04-30
00840319756966Hayden Medical405-470405-4702024-04-12
00840319758892Hayden MedicalE7-0226E7-02262026-03-31
00840319758922Hayden MedicalE7-2234E7-22342026-03-31
00840319758939Hayden Medical210-179210-1792026-03-31
00840319758885Hayden MedicalE5-6271E5-62712026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10