FDA.reportPublic FDA data

Duckworth & Kent

Primary DI
05055313818939
Brand
Duckworth & Kent
Company
DUCKWORTH AND KENT LIMITED
Model
6-615
Catalog number
6-615
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
05055313818939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055313818939050553138189395055313818939

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
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

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
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
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 Surgical®SYMMETRY SURGICAL 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 Surgical®SYMMETRY SURGICAL INC.HNX2024-08-12
00887482111482Symmetry Surgical®SYMMETRY SURGICAL INC.HNX2024-08-12
00887482111499Symmetry Surgical®SYMMETRY SURGICAL INC.HNX2024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCHNX2024-06-03
08175700156110Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
08175700156127Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
03700483602629ONEMORIA SAHNX2023-12-28
03700483603459ONEMORIA SAHNX2023-12-28