FDA.reportPublic FDA data

Windsor Knife

Primary DI
05060510712126
Brand
Windsor Knife
Company
CORE SURGICAL LIMITED
Model
WK220BU
Catalog number
WK220BU
Device description
Windsor Slit Knife / Keratome 2.20mm angled. Single bevel up full handle. Sterile. Single use
Published
2024-04-01
Public version status
New
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
15060510712123PackageGS110In Commercial Distribution
05060510712126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506051071212315060510712123
05060510712126050605107121265060510712126

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
236541301
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060510711747Windsor KnifeWK19GBUWK19GBU2024-04-01
05060510711754Windsor KnifeWK20GBUWK20GBU2024-04-01
05060510711761Windsor KnifeWK21GBUWK21GBU2024-04-01
05060510711778Windsor KnifeWK22GBUWK22GBU2024-04-01
05060510711785Windsor KnifeWK23GBUWK23GBU2024-04-01
05060510711792Windsor KnifeWK24GBUWK24GBU2024-04-01
05060510712072Windsor KnifeWK170BUWK170BU2024-04-01
05060510712089Windsor KnifeWK180BUWK180BU2024-04-01
05060510712096Windsor KnifeWK190BUWK190BU2024-04-01
05060510712102Windsor KnifeWK200BUWK200BU2024-04-01
05060510712119Windsor KnifeWK210BUWK210BU2024-04-01
05060510712133Windsor KnifeWK230BUWK230BU2024-04-01
05060510712140Windsor KnifeWK240BUWK240BU2024-04-01
05060510712157Windsor KnifeWK250BUWK250BU2024-04-01
05060510712164Windsor KnifeWK260BUWK260BU2024-04-01
05060510712171Windsor KnifeWK265BUWK265BU2024-04-01
05060510712188Windsor KnifeWK270BUWK270BU2024-04-01
05060510712195Windsor KnifeWK275BUWK275BU2024-04-01
05060510712201Windsor KnifeWK280BUWK280BU2024-04-01
05060510712218Windsor KnifeWK285BUWK285BU2024-04-01

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