FDA.reportPublic FDA data

Duckworth & Kent

Primary DI
05055313810278
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
6-635-3
Catalog number
6-635-3
Device description
Scleral Depressor
Published
2022-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNXDepressor, Orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055313810278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055313810278050553138102785055313810278

GMDN Terms#

Term, Definition table
TermDefinition
Orbital depressor, reusableA hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it does not provide illumination. Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. It is usually made of metal. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055313824497Duckworth & Kent6-6766-6762022-08-31
05055313800415Duckworth & Kent1-500B1-500B2022-08-31
05055313806646Duckworth & Kent4-1254-1252022-08-31
05055313808718Duckworth & Kent6-090-36-090-32022-08-31
05055313811640Duckworth & Kent8-615-18-615-12022-08-31
05055313813385Duckworth & Kent9-5599-5592022-08-31
05055313813415Duckworth & Kent9-560-19-560-12022-08-31
05055313826453Duckworth & Kent8-6038-6032022-08-31
05055313827047Duckworth & Kent6-615-16-615-12022-08-31
05055313830221Duckworth & Kent6-090-76-090-72022-08-31
05055313832003Duckworth & Kent2-815E2-815E2022-08-31
05055313812623Duckworth & Kent8-732-48-732-42022-08-31
05055313811527Duckworth & Kent8-601-18-601-12022-08-31
05055313805342Duckworth & Kent2-847-42-847-42022-08-31
05055313805465Duckworth & Kent2-8772-8772022-08-31
05055313805489Duckworth & Kent2-878-12-878-12022-08-31
05055313828198Duckworth & Kent2-8372-8372022-08-31
05055313829249Duckworth & Kent2-8382-8382022-08-31
05055313807735Duckworth & Kent4-6214-6212022-08-31
05055313808626Duckworth & Kent6-086-56-086-52022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451339212INAMIINAMI & CO., LTD.HNX2026-01-29
04547451339045InamiINAMI & CO., LTD.HNX2025-12-05
04058935013394Depressor Scleral FlynnBausch & Lomb GmbHHNX2025-10-26
00757770483235Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770498765Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770500444Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770524914Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00194613011604MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613011628MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613109738MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
G412DP20600MR PHACOCrestpoint Management LimitedHNX2025-05-27
00194613119959MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-03-21
00757770406685Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770414703Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770425136Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770432097Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770435326Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00192896120273Schepens Scleral DepressorSONTEC INSTRUMENTS, INC.HNX2024-10-15
00757770426676Bausch + LombBausch & Lomb IncorporatedHNX2024-08-26
00887482049297Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNX2024-08-20
00194613087753MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087760MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087777MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087821MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00887482111475Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111482Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111499Symmetry FlynnASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCHNX2024-06-03
08175700156110Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
08175700156127Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06