FDA.reportPublic FDA data

MR PHACO

Primary DI
G412PH60920
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH6092
Device description
Golf Club Spud with Rounded-Shaped Sharp tip, Wide-Flat Handle, 117mm Overall Length, Stainless Steel
Published
2025-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNASpud, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNASpud, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G412PH60920PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye spudA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. 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
04251047903090Rosen Phaco SplitterA1 Medical GmbHHNA2026-06-09
04251047903274Lester IOL-ManipulatorA1 Medical GmbHHNA2026-06-09
04251047913549Bechert Nucleus RotatorA1 Medical GmbHHNA2026-06-09
04251047928604Drysdale Nucleus ManipulatorA1 Medical GmbHHNA2026-06-09
05056111322123SurtexSURTEX INSTRUMENTS LTD.HNA2026-05-12
00041533986539Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00041533996538Bruder KarpeckiThe Hilsinger Company Parent, LlcHNA2026-02-25
00194613004521MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005344MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005351MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613005368MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613030643MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613091859MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121792MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
00194613121969MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-08-01
G412PH60930MR PHACOCrestpoint Management LimitedHNA2025-06-07
00194613005337MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613005375MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613021139MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613039899MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00194613053932MSI Precision Specialty InstrumentsMed Saver, Inc.HNA2025-03-21
00757770408993Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770414284Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00757770418893Bausch + LombBausch & Lomb IncorporatedHNA2024-11-21
00887482108628Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HNA2024-08-20
G586OP7125400Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
G586OP7125540Novo SurgicalNOVO SURGICAL, INC.HNA2023-12-18
00190776355371MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776355388MillenniumAvalign Technologies, Inc.HNA2023-11-17
00190776069575AvalignAvalign Technologies, Inc.HNA2023-06-23