FDA.reportPublic FDA data

Aqualumen

Primary DI
08600134032018
Brand
Aqualumen
Company
PLU OPHTHALMIC, INC.
Model
AL-1001
Catalog number
AL-1001
Device description
ophthalmic Cannula
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
08600134032025PackageGS15In Commercial Distribution
08600134032018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600134032025086001340320258600134032025
08600134032018086001340320188600134032018

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.

Contacts#

Phone, Email table
PhoneEmail
+1 (952) 797-2287noverbo@pluophthalmic.com

Regulatory Flags#

DUNS number
138315397
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434908MillenniumAvalign Technologies, Inc.HMX2026-10-14
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