FDA.reportPublic FDA data

Nagahara Phaco-Chopper

Primary DI
04251047903755
Brand
Nagahara Phaco-Chopper
Company
A1 Medical GmbH
Model
HS-0360
Device description
1.25mm tip, offset blade, angled 60°, right
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04251047903755PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251047903755042510479037554251047903755

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999info@a1-medical.com

Regulatory Flags#

DUNS number
342514232
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251047903076Kuglen Iris Hook and Lens ManipulatorHS-0000TS2026-06-09
04251047903090Rosen Phaco SplitterHS-0010TS2026-06-09
04251047903151Nagahara Phaco-ChopperHS-0040TS2026-06-09
04251047903175Nagahara Phaco-ChopperHS-0050TS2026-06-09
04251047903274Lester IOL-ManipulatorHS-0110TS2026-06-09
04251047903359Sinskey II Lens Manipulating HookHS-0150TS2026-06-09
04251047903571Rowen Phaco Spatula & Bechert Nucleus RotatorHS-0260TS2026-06-09
04251047903632Chang Phaco ChopperHS-0310TS2026-06-09
04251047904745Sinskey II Lens Manipulating HookHS-06902026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorHS-09402026-06-09
04251047906688Hofmann-Thornton Fixation RingHS-16102026-06-09
04251047913549Bechert Nucleus RotatorHS-0630C2026-06-09
04251047924804Sterilizing CaseMIS-02102026-06-09
04251047926389Sterilization Tray with LidMIS-06112026-06-09
04251047928604Drysdale Nucleus ManipulatorHS-0091TS2026-06-09
04251047930386Double-level Sterilization TrayMIS-06152026-06-09
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKHS-0007TS2026-06-09
04251047935398Gerten Easy Liquid Bubble DMEKHS-0008TS2026-06-09
04251047900174Kratz-Barraquer Wire SpeculumES-00902026-05-29
04251047900655Lieberman Eye SpeculumES-03402026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903175Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
04251047903632Chang 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
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G223140461200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
G412CA14030MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14040MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14050MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14060MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14070MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14080MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14090MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14100MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14110MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14120MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14130MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14140MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14150MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14160MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14170MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14180MR PHACOCrestpoint Management LimitedHMX2025-05-27
G412CA14190MR PHACOCrestpoint Management LimitedHMX2025-05-27