FDA.reportPublic FDA data

Phaco Chopper Ambidextrous

Primary DI
05060480407732
Brand
Phaco Chopper Ambidextrous
Company
BLINK MEDICAL LIMITED
Model
41-4004
Published
2022-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HNCSpecula, Ophthalmic
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060480402232PackageGS110In Commercial Distribution
05060480407732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060480402232050604804022325060480402232
05060480407732050604804077325060480407732

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, single-useA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation/implantation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
738288096
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
05056785304678Enucleation Kit - Vision Gift67-00342026-09-25
05060480407480Scissors Enucleation21-50052026-09-25
05056785304555Cannula Kit 1 - San Jose67-00322026-07-31
05056785303657CANNULA KIT 1 - KAISER PERMANENTE MARTINEZ67-0009A2026-05-12
05056785303633Cataract Inst Set - Spokane Anderson67-0028A2026-05-06
05056785302971Kratz Plastic Mechanical Speculum31-30052026-02-04
05056785302995Plastic Solid Bladed Mechanical Speculum31-30062026-02-04
05056785303350Double Ended Y and ICL Shaped Manipulator41-90152026-02-04
05056785302988Kratz Plastic Mechanical Speculum31-30052026-02-04
05056785303008Plastic Solid Bladed Mechanical Speculum31-30062026-02-04
05056785303367Double Ended Y and ICL Shaped Manipulator41-90152026-02-04
05056785302445Bonn Forceps Straight 0.12mm Toothed, O/L 106mm10-11082025-09-19
05056785303336Connor Wand41-4013BNS2026-01-26
05056785303343Connor Wand41-4013BNS2026-01-26
05056785303251Cataract Instrument Pack - UCM67-00302025-12-11
05056785303268Cataract Instrument Pack - UCM67-00302025-12-11
05056785302698Lenticule Removal Forceps, Serrated Jaw, Direct Action11-90022025-11-14
05056785302711Lenticule Extraction Forceps, Serrated Jaw, Cross Action11-90042025-11-14
05056785302735ICL Loading Forceps, Smooth Jaw, Direct Action11-90012025-11-14
05056785302759ICL Loading Forceps, Smooth Jaw, Cross Action11-90032025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700483630219MORIAMORIA SAHNQ2026-09-25
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G22314029320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-08-03
00190776407452MillenniumAvalign Technologies, Inc.HNC2026-07-31
B382S340861340Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
B382S344922000Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
00198506092145ELMED INCORPORATEDELMED INCORPORATEDHNQ2026-07-27
G22312042490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNC2026-07-27
G22312240810Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223140340L0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223145830T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
00190776400378MillenniumAvalign Technologies, Inc.HNQ2026-07-17
00190776397074MillenniumAvalign Technologies, Inc.HNC2026-07-16
00190776398682MillenniumAvalign Technologies, Inc.HNC2026-07-16
00190776395728MillenniumAvalign Technologies, Inc.HNQ2026-07-14
00190776396770MillenniumAvalign Technologies, Inc.HNC2026-07-14
13700773729644IRIS RETRACTOR 5 HOOKSFCI S A S FCI 20 22HNQ2026-07-09
G346E12710Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNC2026-06-23
00757770451531Bausch + LombBausch & Lomb IncorporatedHNQ2026-06-22
00757770668540Bausch + LombBausch & Lomb IncorporatedHNC2026-06-22
00198506091513ELMED INCORPORATEDELMED INCORPORATEDHNC2026-06-10
00198506091520ELMED INCORPORATEDELMED INCORPORATEDHNC2026-06-10
04251047903076Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047903359Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047904745Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047900174Kratz-Barraquer Wire SpeculumA1 Medical GmbHHNC2026-05-29
04251047900655Lieberman Eye SpeculumA1 Medical GmbHHNC2026-05-29