FDA.reportPublic FDA data

Swiss Coaxial I/A

Primary DI
07630055243164
Brand
Swiss Coaxial I/A
Company
Medicel AG
Model
SMS165P
Catalog number
SMS165P
Device description
The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07630055243164PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055243164076300552431647630055243164

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

Contacts#

Phone, Email table
PhoneEmail
+41717271050info@medicel.com

Regulatory Flags#

DUNS number
487158263
Device count
1
Premarket exempt
true
Lot or batch
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
07630055243768Phaco Accessory SetPA603953PA6039532023-12-01
07630055214850Accuject REFRA 2.9 InjectorREV.PAR29002023-12-08

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Primary DI, Brand, Company table
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G412CA14060MR PHACOCrestpoint Management LimitedHMX2025-05-27
07612717072091FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
07612717072107FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
07612717072060FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-25
07612717072077FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-25
08052276019639Silicone Oil Infusion Line 23G for TocarAKTIVE SRLHMX2024-01-11
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