FDA.reportPublic FDA data

MANI Ophthalmic Knife

Primary DI
14546951400016
Brand
MANI Ophthalmic Knife
Company
MANI, INC.
Model
MST45 Straight 45°
Device description
MANI Ophthalmic Knife
Published
2022-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
14546951400016PrimaryGS10
74546951400018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1454695140001614546951400016
7454695140001874546951400018

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic knife, single-useA 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 silicon (i.e., a brittle metalloid material) blades. This is a single-use device.

Regulatory Flags#

DUNS number
690622428
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14546951639997MANI MICRO FORCEPSSquare 25G 360 Grip 33mm2026-09-18
14546951640009MANI MICRO FORCEPSRound 25G 360 Grip 33mm2026-09-18
14546951640016MANI MICRO FORCEPSILM 25G 360 Grip 33mm2026-09-18
14546951640023MANI MICRO FORCEPSSquare 27G 360 Grip 33mm2026-09-18
14546951640030MANI MICRO FORCEPSRound 27G 360 Grip 33mm2026-09-18
14546951640047MANI MICRO FORCEPSILM 27G 360 Grip 33mm2026-09-18
14546951640054MANI MICRO FORCEPSEXFine 27G 360 Grip 33mm2026-09-18
14546951640061MANI MICRO FORCEPSSquare 25G 360 Grip 28mm2026-09-18
14546951640078MANI MICRO FORCEPSRound 25G 360 Grip 28mm2026-09-18
14546951640085MANI MICRO FORCEPSILM 25G 360 Grip 28mm2026-09-18
14546951640092MANI MICRO FORCEPSSquare 27G 360 Grip 28mm2026-09-18
14546951640108MANI MICRO FORCEPSRound 27G 360 Grip 28mm2026-09-18
14546951640115MANI MICRO FORCEPSILM 27G 360 Grip 28mm2026-09-18
14546951640122MANI MICRO FORCEPSEXFine 27G 360 Grip 28mm2026-09-18
14546951616721MANI Ophthalmic KnifeMSL24CH Slit-Angled 2.4mm CH2026-07-23
14546951627383MANI Ophthalmic KnifeMSL22CH Slit-Angled 2.2mm CH2026-07-23
14546951627390MANI Ophthalmic KnifeMSL27CH Slit-Angled 2.75mm CH2026-07-23
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-08-07
00190776408824MillenniumAvalign Technologies, Inc.HNN2026-08-03
14546951616721MANI Ophthalmic KnifeMANI, INC.HNN2026-07-23
14546951627383MANI Ophthalmic KnifeMANI, INC.HNN2026-07-23
14546951627390MANI Ophthalmic KnifeMANI, INC.HNN2026-07-23
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