FDA.reportPublic FDA data

MR PHACO

Primary DI
G412PH95400
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH9540
Device description
Fukuyama Fixation Ring Fixed 13mm x 12mm C Style w/ 10 Degree markings on top, Flat Handle, Stainless Steel
Published
2025-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNHRing, Ophthalmic (Flieringa)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G412PH95400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flieringa ophthalmic ringA circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. 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
G412PH98270MR PHACOPH98272025-06-09
G412PH99970MR PHACOPH99972025-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435194334969AJL Vacuum Centering GuideAJL OPHTHALMIC SAHNH2026-03-12
04058935013547 Ring Fixation Fine Thornton 16Bausch & Lomb GmbHHNH2025-10-26
04058935013554 Ring Fixation Fine-Thornton 13Bausch & Lomb GmbHHNH2025-10-26
00757770418855Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00757770481835Bausch + LombBausch & Lomb IncorporatedHNH2025-08-07
00190776406738MillenniumAvalign Technologies, Inc.HNH2025-07-23
G412PH21150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH21900MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190080MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190090MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190100MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190110MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190120MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190130MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190140MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190150MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190160MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190170MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190180MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190190MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190200MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190210MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190220MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190230MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH2190240MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH95000MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH9500T0MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH95010MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH9502T0MR PHACOCrestpoint Management LimitedHNH2025-06-07
G412PH9503T0MR PHACOCrestpoint Management LimitedHNH2025-06-07