FDA.reportPublic FDA data

MR PHACO

Primary DI
G412PH6005T0
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH6005T
Device description
Nichamin Triple Chopper Unique Multi-Directional Cutting Edge, Angled/Vaulted 10mm from bend to tip, Round Knurled Handle, 114mm Overall Length, Titanium
Published
2025-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
G412PH6005T0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
836285668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G412CA11700MR PHACOCA11702025-06-09
G412DK70030MR PHACODK70032025-06-09
G412MMP2480MR PHACOMMP2482025-06-09
G412PH10200MR PHACOPH10202025-06-09
G412PH10270MR PHACOPH10272025-06-09
G412PH19980MR PHACOPH19982025-06-09
G412PH20310MR PHACOPH20312025-06-09
G412PH21080MR PHACOPH21082025-06-09
G412PH21190MR PHACOPH21192025-06-09
G412PH22050MR PHACOPH22052025-06-09
G412PH22060MR PHACOPH22062025-06-09
G412PH22180MR PHACOPH22182025-06-09
G412PH227410MR PHACOPH2274-12025-06-09
G412PH22780MR PHACOPH22782025-06-09
G412PH62530MR PHACOPH62532025-06-09
G412PH94030MR PHACOPH94032025-06-09
G412PH94071T0MR PHACOPH94071T2025-06-09
G412PH9408T0MR PHACOPH9408T2025-06-09
G412PH95400MR PHACOPH95402025-06-09
G412PH98270MR PHACOPH98272025-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417581MillenniumAvalign Technologies, Inc.HNQ2026-03-04
00810123209828Adler Instrument CompanyAdler, Inc.HNQ2026-02-10
00190776415662MillenniumAvalign Technologies, Inc.HNQ2026-02-02
00840319758663Hayden MedicalHayden Medical, Inc.HNQ2026-01-30
00190776415211MillenniumAvalign Technologies, Inc.HNQ2026-01-27
00840319758557Hayden MedicalHayden Medical, Inc.HNQ2025-12-31
G2231394680Sinskey lens manipulating hookMedetz Surgical Instruments LLCHNQ2025-12-16
00852194002076HAI HookHightech American Industrial Labs IncHNQ2025-12-15
09348811119902INKAThe Trustee for KAISER FAMILY TRUSTHNQ2025-12-03
00757770636228Bausch + LombBausch & Lomb IncorporatedHNQ2025-11-14
00757770645732Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00757770683666Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00840319758250Hayden MedicalHayden Medical, Inc.HNQ2025-09-12
00840319758229Hayden MedicalHayden Medical, Inc.HNQ2025-08-29
00757770421701Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-22
00757770636884Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
00757770673964Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
G22312244990Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G2231458300Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G223997034050Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00757770478613Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770507481Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770510962Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535514Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535682Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00194613004224MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004446MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004453MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004583MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004590MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01