FDA.reportPublic FDA data

Diamatrix Ltd.

Primary DI
00813059018144
Brand
Diamatrix Ltd.
Company
Diamatrix
Model
N01910
Catalog number
N01910
Device description
Triple 90 Chisel Diamond Blade, 1.0mm Wide, Sharp Sides Beveled, 4.5mm Length
Published
2022-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNNKnife, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813059018144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813059018144008130590181448130590181440813059018144

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
809555139
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
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
04251047902956Kelly Descemet Membrane PunchA1 Medical GmbHHNN2026-05-29
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033802Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033819Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033826Scleral Knife Angled AKTIVE SRLHNN2024-01-17
08052276033833Stab Knife 15° AKTIVE SRLHNN2024-01-17
08052276033840Stab Knife 15° with protectionAKTIVE SRLHNN2024-01-17
08052276033857Stab Knife 22,5°AKTIVE SRLHNN2024-01-17
08052276033864Stab Knife 22,5° with protectionAKTIVE SRLHNN2024-01-17
08052276033871Stab Knife 30° AKTIVE SRLHNN2024-01-17
08052276033888Stab Knife 30° with protectionAKTIVE SRLHNN2024-01-17
08052276033895Stab Knife 45° AKTIVE SRLHNN2024-01-17
08052276033901Stab Knife 45° with protectionAKTIVE SRLHNN2024-01-17
08052276033918Blunt tip Knife 4.0 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17