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
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
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
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

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Primary DI, Brand, Company table
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00194613111380MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00757770435432Bausch + LombBausch & Lomb IncorporatedHRH2025-07-30
G412PH98270MR PHACOCrestpoint Management LimitedHRH2025-06-09
G412PH62270MR PHACOCrestpoint Management LimitedHRH2025-05-27
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00757770430345Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
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