FDA.report

Duckworth & Kent

Primary DI
05055313810971
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
6-912
Catalog number
6-912
Device description
Membrane Spatula
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
HNDSpatula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055313810971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055313810971050553138109715055313810971

GMDN Terms

TermDefinition
Epiretinal/inner limiting membrane scraper, reusableA hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer), intended to effectively grip/lift the membrane to allow for further manipulation (e.g., with forceps). This is a reusable device intended to be sterilized prior to use.

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

Other Devices Sharing Product Codes

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