FDA.reportPublic FDA data

Duckworth & Kent

Primary DI
05055313811527
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
8-601-1
Catalog number
8-601-1
Device description
Cannula
Published
2022-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055313811527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055313811527050553138115275055313811527

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+441462893254info@duckworth-and-kent.co.uk

Regulatory Flags#

DUNS number
217182583
Device count
1
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
05055313824497Duckworth & Kent6-6766-6762022-08-31
05055313800415Duckworth & Kent1-500B1-500B2022-08-31
05055313806646Duckworth & Kent4-1254-1252022-08-31
05055313808718Duckworth & Kent6-090-36-090-32022-08-31
05055313811640Duckworth & Kent8-615-18-615-12022-08-31
05055313813385Duckworth & Kent9-5599-5592022-08-31
05055313813415Duckworth & Kent9-560-19-560-12022-08-31
05055313826453Duckworth & Kent8-6038-6032022-08-31
05055313827047Duckworth & Kent6-615-16-615-12022-08-31
05055313830221Duckworth & Kent6-090-76-090-72022-08-31
05055313832003Duckworth & Kent2-815E2-815E2022-08-31
05055313812623Duckworth & Kent8-732-48-732-42022-08-31
05055313805342Duckworth & Kent2-847-42-847-42022-08-31
05055313805465Duckworth & Kent2-8772-8772022-08-31
05055313805489Duckworth & Kent2-878-12-878-12022-08-31
05055313828198Duckworth & Kent2-8372-8372022-08-31
05055313829249Duckworth & Kent2-8382-8382022-08-31
05055313807735Duckworth & Kent4-6214-6212022-08-31
05055313808626Duckworth & Kent6-086-56-086-52022-08-31
05055313808862Duckworth & Kent6-099-46-099-42022-08-31

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Primary DI, Brand, Company table
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B382S347671000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891000Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347891190Surgical DirectSurgical Direct, Inc.HMX2026-07-31
B382S347911020Surgical DirectSurgical Direct, Inc.HMX2026-07-31
G223140190270Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-07-27
00190776403843MillenniumAvalign Technologies, Inc.HMX2026-07-21
00190776400569MillenniumAvalign Technologies, Inc.HMX2026-07-19
00860015282040Intrace USAPILOTIS TECH LLCHMX2026-07-03
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04251047903151Nagahara Phaco-ChopperA1 Medical GmbHHMX2026-06-09
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08600088329110Maskin MG Probe 1mmMGD INNOVATIONS, LLCHMX2026-05-07
G22312643590Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2026-04-09
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G346EEC0330Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMX2026-03-18
G22312624110Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMX2025-09-10
07612717072091FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26
07612717072107FINESSE ModifEYEAlcon Laboratories, Inc.HMX2024-09-26