FDA.reportPublic FDA data

Clarus Dual HDMI Enclosure

Primary DI
00810004820807
Brand
Clarus Dual HDMI Enclosure
Company
CLARUS MEDICAL, LLC
Model
CD-HDMI
Catalog number
CD-HDMI
Device description
The Clarus Dual HDMI Enclosure is a device used with a with a Clarus Digital Inspection Scope and is intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The Clarus Dual HDMI Enclosure provides a white light source and facilitates the image from the camera sensor to a monitor. This is a reusable device.
Published
2022-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810004820807Direct MarkingGS10
10810004820804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004820807008100048208078100048208070810004820807
1081000482080410810004820804

GMDN Terms#

Term, Definition table
TermDefinition
Instrument inspection scopeAn endoscope-like device with a flexible working length intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The device includes a fibreoptic bundle or charge-coupled device (CCD) to convey images. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
010316284
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810004820125Light Cable, ACMI-Wolf/Dyonics, 1mm5161-1005161-1002024-12-23
10810004820132Light Cable, ACMI-Olympus, 1mm5160-1005160-1002024-12-23
10810004820149Light Cable, ACMI-Storz, 1mm5154-1005154-1002024-12-23
10810004820460Light Cable, ACMI-ACMI, 1mm5161-1005161-1002024-12-30
10810004820705Adapter, ACMI5196-9015196-9012024-12-23
10810004820712Adapter, Olympus5196-9025196-9022024-12-23
10810004820729Adapter, Storz5196-9035196-9032024-12-23
10810004820736Adapter, Wolf/Dyonics5196-9045196-9042024-12-23
10810004820750Universal Light Cable5196-1005196-1002024-12-23
00810004821064Clarus Digital ChannelScope Endoscope, 21.6cm, 3mm WC2230-5212230-5212026-04-21
00810004821071Clarus Digital ChannelScope Endoscope, 13.0cm, 3mm WC2230-5132230-5132026-04-21
00810004821118Digital MurphyScope Endoscope2125-5152125-5152026-04-21
B06730000100SOS Shikani Optical Stylet, Adult30000-1030000-102016-09-20
B06730000GL0SOS Malleable Stylet, Green Line (Adult)30000-GL30000-GL2016-09-20
B06730000GLS0SOS Malleable Stylet, Adult, Green Line with Stop30000-GLS30000-GLS2016-09-20
B06730001100SOS Shikani Optical Stylet, Pediatric30001-1030001-102016-09-20
B06730003P0PocketScope, pocket endoscope30003-P30003-P2016-09-20
10810004820170Forceps, Cup, Down, 2mm, 28.5cm3220-0023220-0022024-12-30
10810004820316Forceps, Cup with Teeth, 2.0mm x 28.5cm, Down35701357012024-12-30
10810004820323Forceps, Cup with Teeth, 2.0mm x 19.5cm, Down35700357002024-12-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
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