FDA.reportPublic FDA data

Anodyne Surgical

Primary DI
00840516141404
Brand
Anodyne Surgical
Company
Psi/Eye-Ko, Inc.
Model
KA7225
Device description
2.5mm/2.8mm 3D Style Diamond Knife, Angled Holder with Titanium Handle
Published
2023-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00840516141404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840516141404008405161414048405161414040840516141404

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
Ethylene Oxide;Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(800)428-5628info@anodynesurgical.com

Regulatory Flags#

DUNS number
063763833
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840516145839Anodyne Surgical7007D2026-05-12
00840516145747Anodyne SurgicalRx404062026-04-17
00840516145761Anodyne SurgicalRx909052026-04-17
00840516145808Anodyne SurgicalCK20012026-04-17
00840516145815Anodyne SurgicalCK20022026-04-17
00840516142784Anodyne SurgicalAE03-2001-45062025-06-20
00840516142777Anodyne SurgicalAE03-2001-45062025-06-20
00840516142647Anodyne Surgical9903-8FSP2025-06-12
00840516142654Anodyne Surgical9903-8FSP2025-06-12
00840516109893Anodyne Surgical8000-262023-06-21
00840516113326Anodyne Surgical8000-262023-06-21
00840516117454Anodyne Surgical8000-262023-08-30
00840516127842Anodyne Surgical0002F2023-08-23
00840516127859Anodyne Surgical00072023-08-23
00840516127866Anodyne Surgical0018B2023-08-23
00840516127873Anodyne Surgical0020-212023-08-23
00840516127880Anodyne Surgical0020.22023-08-23
00840516127897Anodyne Surgical1000-4.12023-08-23
00840516127903Anodyne Surgical1000-4.22023-08-23
00840516127910Anodyne Surgical1001-4.12023-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810163790546Diamatrix Ltd.DiamatrixHNN2026-03-24
00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-02-23
00757770635382Bausch + LombBausch & Lomb IncorporatedHNN2026-01-27
00850072675008MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675015MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675022MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675039MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675046MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675091MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675107MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675206MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675213MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
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00850072675237MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675244MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675251MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16