FDA.report

Duckworth & Kent

Primary DI
05055313809135
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
6-140
Catalog number
6-140
Device description
Cataract Support
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

Related Records

Contact Domains

Product Codes

CodeName
HNIRetractor, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055313809135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055313809135050553138091355055313809135

GMDN Terms

TermDefinition
Intraocular retractor, reusableA dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+441462893254info@duckworth-and-kent.co.uk

Regulatory Flags

DUNS number
217182583
Device count
1
DM exempt
true
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 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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