FDA.reportPublic FDA data

Duckworth & Kent

Primary DI
05055313810834
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
6-866
Catalog number
6-866
Device description
Epithelial Separator
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
HRHTrephine, Manual, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055313810834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055313810834050553138108345055313810834

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. 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
05055313811527Duckworth & Kent8-601-18-601-12022-08-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841668146507BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146514BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146521BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146538BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146545BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146552BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146569BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146576BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146590BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146606BarronKATENA PRODUCTS, INC.HRH2026-06-10
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05055445956318SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956325SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12