FDA.reportPublic FDA data

MR PHACO

Primary DI
G412PH31130
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH3113
Device description
Barraquer Needle Holder Standard Curved 10mm Smooth Jaws, With Lock, Round Knurled Handle, 135mm Overall Length, Stainless Steel
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
G412PH31130PrimaryHIBCC0

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
G412PH10400MR PHACOCrestpoint Management LimitedHNM2025-06-03