FDA.reportPublic FDA data

Duckworth & Kent

Primary DI
05055313828174
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
6-836
Catalog number
6-836
Device description
SMILE Dissector
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055313828174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055313828174050553138281745055313828174

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055313800019Duckworth & Kent1-1101-1102022-08-31
05055313800033Duckworth & Kent1-1111-1112022-08-31
05055313800057Duckworth & Kent1-111B1-111B2022-08-31
05055313800071Duckworth & Kent1-1121-1122022-08-31
05055313800101Duckworth & Kent1-1161-1162022-08-31
05055313800118Duckworth & Kent1-1181-1182022-08-31
05055313800125Duckworth & Kent1-1201-1202022-08-31
05055313800149Duckworth & Kent1-1211-1212022-08-31
05055313800200Duckworth & Kent1-2111-2112022-08-31
05055313800217Duckworth & Kent1-211B1-211B2022-08-31
05055313800262Duckworth & Kent1-2181-2182022-08-31
05055313800279Duckworth & Kent1-2191-2192022-08-31
05055313800330Duckworth & Kent1-3121-3122022-08-31
05055313800385Duckworth & Kent1-4101-4102022-08-31
05055313800408Duckworth & Kent1-5001-5002022-08-31
05055313800415Duckworth & Kent1-500B1-500B2022-08-31
05055313800422Duckworth & Kent1-5011-5012022-08-31
05055313800446Duckworth & Kent1-5101-5102022-08-31
05055313800484Duckworth & Kent1-7001-7002022-08-31
05055313800491Duckworth & Kent1-7051-7052022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EP19A0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-03-24
B382S344901020Surgical DirectSurgical Direct, Inc.HND2026-03-09
G34EP223R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-02-27
G3446EP219SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-02-16
00757770636631Bausch + LombBausch & Lomb IncorporatedHND2026-02-04
05056785303367Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
B382S344901080Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344932020Surgical DirectSurgical Direct, Inc.HND2026-02-04
B382S344961000Surgical DirectSurgical Direct, Inc.HND2026-02-04
05056785303343Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
00840319758540Hayden MedicalHayden Medical, Inc.HND2025-12-31
00840319758403Hayden MedicalHayden Medical, Inc.HND2025-12-24
00840319758410Hayden MedicalHayden Medical, Inc.HND2025-12-24
00852194002144HAI SpatulaHightech American Industrial Labs IncHND2025-12-16
G223M1129350Femtosecond SpatulaMedetz Surgical Instruments LLCHND2025-12-16
00757770676361Bausch + LombBausch & Lomb IncorporatedHND2025-12-12
B382S34543110T0Surgical DirectSurgical Direct, Inc.HND2025-12-10
B382S9344951010Surgical DirectSurgical Direct, Inc.HND2025-12-10
00757770695522Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770697892Bausch + LombBausch & Lomb IncorporatedHND2025-11-16
00757770688524Bausch + LombBausch & Lomb IncorporatedHND2025-11-14
B382S340861160Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S344101420Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382S4088010Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9340311000Surgical DirectSurgical Direct, Inc.HND2025-11-11
B382SD9343771110Surgical DirectSurgical Direct, Inc.HND2025-11-11
G346EP55L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-26
G346EP1650Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-23
B382S9340861010Surgical DirectSurgical Direct, Inc.HND2025-09-22
G346EC222SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-09-18