FDA.reportPublic FDA data

Diamatrix

Primary DI
00813059016133
Brand
Diamatrix
Company
Diamatrix
Model
H439-AL-S
Catalog number
H439-AL-S
Device description
Diamatrix Nucleus Chopper, Angled, Curved interior cutting edge with .5mm olive shaped tip, Intended to be used in the left hand, Slightly Angled 15mm from bend to tip, Round knurled Handle, 117mm total length, Stainless Steel
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813059016133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059016133008130590161338130590161330813059016133

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. 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
809555139
Device count
1
DM exempt
true
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
00810163790577Diamatrix Ltd.C6162026-05-26
00810163790553Diamatrix Ltd.G151G1512026-04-29
00813059013354Dacrios Opthalmic KnivesD3210D32102026-04-14
00810163790546Diamatrix Ltd.N04350.8N04350.82026-03-24
00813059013491Dacrios Opthalmic KnivesD3705D37052026-03-19
00810163790430Diamatrix Ltd.F003F0032025-10-21
00810163790447Diamatrix Ltd.H805-1.5H805-1.52025-10-21
00810163790454Diamatrix Ltd.H805-3H805-32025-10-21
00810163790461Diamatrix Ltd.F300S.5F300S.52025-10-21
00810163790478Inami & Co., Ltd.S-325S-3252025-10-20
00810163790423Diamatrix Ltd.C223A-25C223A-252025-10-07
00810163790416Diamatrix Ltd.F775S2025-08-06
00810163790386Diamatrix Ltd.C119-21C119-212025-06-30
00810163790393Diamatrix Ltd. H188FH188F2025-06-30
00810163790409Diamatrix Ltd.C027-8C027-82025-06-30
00810163790348Diamatrix Ltd.F002F0022025-06-13
00810163790317Diamatrix Ltd.H854H8542025-06-06
00810163790324Diamatrix Ltd.IT-.5-CIT-.5-C2025-06-06
00810163790331Diamatrix Ltd.F445S.5F445S.52025-05-27
00810163790355Diamatrix Ltd.F040-1.2F040-1.22025-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776420093MillenniumAvalign Technologies, Inc.HNQ2026-04-16
00190776419912MillenniumAvalign Technologies, Inc.HNQ2026-04-15
00190776414214MillenniumAvalign Technologies, Inc.HNQ2025-10-22
00810163790447Diamatrix Ltd.DiamatrixHNQ2025-10-21
00810163790454Diamatrix Ltd.DiamatrixHNQ2025-10-21
00190776412616MillenniumAvalign Technologies, Inc.HNQ2025-10-03
00190776412005MillenniumAvalign Technologies, Inc.HNQ2025-10-01
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00810163790331Diamatrix Ltd.DiamatrixHNQ2025-05-27
10649111487934Sklar InstrumentsSKLAR CORPORATIONHNQ2025-01-03
G2231196710Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-09-19
00810123480883Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480890Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480906Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
00810123480913Vortex Surgical IncVortex Surgical, Inc.HNQ2023-02-02
G2231196700Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2023-01-12
14026704790675PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799579PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799661PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799678PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799685PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799692PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799708PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799715PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08
14026704799722PILLINGTELEFLEX INCORPORATEDHNQ2022-12-08