FDA.reportPublic FDA data

Duckworth & Kent

Primary DI
05055313816287
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
9-781
Catalog number
9-781
Device description
Ring Marker
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
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055313816287PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055313816287050553138162875055313816287

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

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
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00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
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G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
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B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
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B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05
B382SD9345561010Surgical DirectSurgical Direct, Inc.HMR2025-09-18
B382SD934557100Surgical DirectSurgical Direct, Inc.HMR2025-09-18
00757770492312Bausch + LombBausch & Lomb IncorporatedHMR2025-08-04
00194613001964MSI Precision Specialty InstrumentsMed Saver, Inc.HMR2025-08-01