FDA.reportPublic FDA data

MR PHACO

Primary DI
G412PH99980
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH9998
Device description
"10""length .030"" ID Silicone tubing"
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G412PH99980PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration tubing, reusableA length of flexible, noninvasive tube intended to connect an ophthalmic cannula to an external device(s) [e.g., pump, bottles] for infusion, irrigation and/or aspiration (suction) during an ophthalmic procedure [e.g., tamponade, glaucoma treatment]. It is made of polymer material(s), may incorporate single- or double-lumen and may be provided in rolls from which required lengths are cut, or in predetermined lengths. It may be provided with simple connectors; however, it does not include other associated items (e.g., clamp, spike) [i.e., not a tubing set]. This is a reusable device intended to be sterilized prior to use.

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
00848530087142Respiratory AccessorySunset Healthcare Solutions, Inc.BYX2025-11-19
00848530070236CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00848530070281CPAP TubingSunset Healthcare Solutions, Inc.BYX2025-05-19
00789091681564Oxygen TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681595CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00789091681601CPAP TubeSunset Healthcare Solutions, Inc.BYX2025-05-13
00848530089375Suction KitSunset Healthcare Solutions, Inc.BYX2025-04-15
00848530094232AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094256AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094263AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094270AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094294AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094317AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094331AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094348AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094355AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094362AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094379AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094386AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094393AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094409AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094416AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094423AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094430AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094447AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094454AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094461AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094478AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094485AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07
00848530094492AnesthesiaSunset Healthcare Solutions, Inc.BYX2024-08-07