FDA.report

Duckworth & Kent

Primary DI
05055313813330
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
9-557
Catalog number
9-557
Device description
Speculum
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
05055313813330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055313813330050553138133305055313813330

GMDN Terms

TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. 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
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 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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