FDA.report

Dynamic Phaco Set Sophi - 20G/30°

Primary DI
07630055243294
Brand
Dynamic Phaco Set Sophi - 20G/30°
Company
This AG
Model
1401-3020
Catalog number
1401-3020
Published
2026-02-11
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

Related Records

Product Codes

CodeName
HQCUnit, Phacofragmentation

Product Code Classifications

CodeDeviceSpecialtyClass
HQCUnit, PhacofragmentationOphthalmic2

Premarket Submissions

SubmissionSupplement
K250501000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K250501000System SophiThis AG2025-11-14HQC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630055253293PrimaryGS10
07630055243294Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630055253293076300552532937630055253293
07630055243294076300552432947630055243294

GMDN Terms

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

Regulatory Flags

DUNS number
480032801
Device count
10
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04251954900014Phaco Handpiece Sophi ECO1401-20101401-20102026-02-11
07630055210449Phaco Set Sophi - 20G/30°1401-20201401-20202026-02-11
07630055210456Phaco Set Sophi - 21G/30°1401-20211401-20212026-02-11
07630055210463Phaco Set Sophi - 23G/30°1401-20231401-20232026-02-11
07630055210869Phaco Set Sophi - 20G/Curved1401-27201401-27202026-02-11
07630055210876Phaco Set Sophi - 21G/Curved1401-27211401-27212026-02-11
07630055210883Phaco Set Sophi - 23G/Curved1401-27231401-27232026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.451401-28211401-28212026-02-11
07640179410236SOPHI A1801-01001801-01002026-02-11
07640179410755Cassette Peristaltic Sophi 1401-52001401-52002026-02-11
07640179410779Cassette Peristaltic & Venturi Sophi1401-52101401-52102026-02-11
07640179410793Cassette Peristaltic Sophi ECO1401-52031401-52032026-02-11
07640179410007SOPHI1401-0100-ACW1401-0100-ACW2026-02-10
07640179410090SOPHI1401-0100-A1401-0100-A2026-02-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07630055210449Phaco Set Sophi - 20G/30°This AGHQC2026-02-11
07630055210456Phaco Set Sophi - 21G/30°This AGHQC2026-02-11
07630055210463Phaco Set Sophi - 23G/30°This AGHQC2026-02-11
07630055210869Phaco Set Sophi - 20G/CurvedThis AGHQC2026-02-11
07630055210876Phaco Set Sophi - 21G/CurvedThis AGHQC2026-02-11
07630055210883Phaco Set Sophi - 23G/CurvedThis AGHQC2026-02-11
07630055242884HighVac Phaco Set Sophi - 21G/30° 0.45This AGHQC2026-02-11
07640179410236SOPHI AThis AGHQC2026-02-11
07640179410755Cassette Peristaltic Sophi This AGHQC2026-02-11
07640179410779Cassette Peristaltic & Venturi SophiThis AGHQC2026-02-11
07640179410793Cassette Peristaltic Sophi ECOThis AGHQC2026-02-11
07640179410007SOPHIThis AGHQC2026-02-10
07640179410090SOPHIThis AGHQC2026-02-10
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07630003910339Oertli®Oertli-Instrumente AGHQC2025-12-19
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07630003920178Oertli®Oertli-Instrumente AGHQC2025-09-19
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10380650003239UNITYAlcon Laboratories, Inc.HQC2025-04-07
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10380650003383UNITYAlcon Laboratories, Inc.HQC2025-04-07
10380650003437UNITYAlcon Laboratories, Inc.HQC2025-04-07
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10380650003451UNITYAlcon Laboratories, Inc.HQC2025-04-07