FDA.reportPublic FDA data

Sinskey lens manipulating hook

Primary DI
G2231394680
Brand
Sinskey lens manipulating hook
Company
Medetz Surgical Instruments LLC
Model
13-9468
Device description
Maloney IOL Manipulator .25mm Diameter Teardrop shaped tip, Straight/Vaulted 7mm from tip, Round Knurled Handle, 118mm Overall Length, Stainless Steel
Published
2025-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G2231394680PrimaryHIBCC0

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
8004205135emichaels@medetzsurgical.com

Regulatory Flags#

DUNS number
876570990
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G22312349490Medetz Surgical Instruments12-349492026-08-03
G22312552000Medetz Surgical Instruments12-552002026-08-03
G22314029320Medetz Surgical Instruments14-0293-22026-08-03
G223140475250Medetz Surgical Instruments14-0475-252026-08-03
G223A1140970Medetz Surgical InstrumentsA11-40972026-08-03
G2231114060Medetz Surgical Instruments11-14062026-07-27
G2231119000Medetz Surgical Instruments11-19002026-07-27
G223111901T0Medetz Surgical Instruments11-1901T2026-07-27
G22312042490Medetz Surgical Instruments12-042492026-07-27
G22312240810Medetz Surgical Instruments12-240812026-07-27
G22312408910Medetz Surgical Instruments12-408912026-07-27
G223140190270Medetz Surgical Instruments14-0190272026-07-27
G223140340L0Medetz Surgical Instruments14-0340LT2026-07-27
G223140410T0Medetz Surgical Instruments14-0410-T2026-07-27
G223145830T0Medetz Surgical Instruments14-5830-t2026-07-27
G22315466860Medetz Surgical Instruments15-466862026-07-27
G2231250500Fine Thornton Fixation Ring12-250502022-02-24
G22312643590Medetz Surgical Instruments12-643592026-04-09
G2231349550Ophthalmic Scissors13-49552026-04-09
G223140461200Medetz Surgical Instruments14-0461202026-04-09

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Primary DI, Brand, Company table
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G22314029320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-08-03
B382S340861340Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
B382S344922000Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
00198506092145ELMED INCORPORATEDELMED INCORPORATEDHNQ2026-07-27
G22312240810Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223140340L0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223145830T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
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