FDA.reportPublic FDA data

Phaco Accessory Set

Primary DI
07630055243768
Brand
Phaco Accessory Set
Company
Medicel AG
Model
PA603953
Catalog number
PA603953
Device description
PA603953 COOLFLOW 21G Sleeve, clear
Published
2023-12-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
07630055243768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055243768076300552437687630055243768

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
487158263
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630055214935VISCOJECT 1.8 Injector SetLP604350LP6043502026-04-28
07630055213853VISCOJECT 2.2 Injector SetLP604340LP6043402026-04-24
07630055212023ACCUJECT 2.2-1P INJECTOR SETLP604530LP6045302025-12-09
07630055244055BICEL SOFT TIP I/A curved / 21G terralutionBIT21ASBIT21AS2025-12-09
07630055214584ACCUJECT injector Set 2.1-1PLP604590LP6045902025-09-30
07630055244031BICEL I/A curved / 21G terralutionBIT21A2025-05-28
07630055244048BICEL I/A curved / 23G terralutionBIT23A2025-05-28
07630055241863I/A Coaxial Handpiece Set Sophi - 20G/65°1401-22301401-22302024-11-28
07630055241870I/A Coaxial Handpiece Set Sophi - 21G/45°1401-22211401-22212024-11-28
07630055241887I/A Coaxial Handpiece Set Sophi - 23G/45°1401-22231401-22232024-11-28
07630055241894I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip1401-22431401-22432024-11-28
07630055243287I/A Bimanual Handpiece Set Sophi -21G/Aeroplane1401-21301401-21302024-11-28
07630055243959I/A Coaxial Handpiece Set Sophi - 20G/45°1401-22202024-11-28
07630055240835Phaco Accessory SetPA603901PA6039012023-12-01
07630055240859Phaco Accessory SetPA603903PA6039032023-12-01
07630055240866Phaco Accessory SetPA603904PA6039042023-12-01
07630055243744Phaco Accessory SetPA603951PA6039512023-12-01
07630055243751Phaco Accessory SetPA603952PA6039522023-12-01
07630055214850Accuject REFRA 2.9 InjectorREV.PAR29002023-12-08
07630055240217Swiss Coaxial I/ASMS355PSMS355P2023-12-06

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