FDA.reportPublic FDA data

MR PHACO

Primary DI
G412PH10400
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH1040
Device description
Needle Holder, Locking, 7mm Delicate, curved jaw, round handle.
Published
2025-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G412PH10400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic suture/needle passerA hand-held manual ophthalmic surgical instrument designed for passing (driving) a suture needle with a pre-attached suture through ocular structures (e.g., ciliary sulcus) during an ophthalmic surgical procedure (e.g., securing the haptics of an intraocular lens during implantation). It is a syringe-like device with a distal tip and a manual needle-driving mechanism. 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
G346EEN008Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2026-04-20
08800268430111LYNKS Frontalis SlingLynk Solutec Inc.HNM2026-03-03
G346EEN0132Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-12-17
04058935011574Osher Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011581Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011598Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011604Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011611Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011628McPherson Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011635Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011642Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011659Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011666Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011673Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011680Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011697Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011703Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011710Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011727Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011734Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011741Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011758Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011765Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011772Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011789Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011796Derf Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
G346EEN010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-07-07
G223112750WHMC0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G2231138500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G412PH10410MR PHACOCrestpoint Management LimitedHNM2025-06-03