FDA.reportPublic FDA data

Clarus TURBO LED Light Source

Primary DI
B06751972010
Brand
Clarus TURBO LED Light Source
Company
CLARUS MEDICAL, LLC
Model
5197-201
Catalog number
5197-201
Device description
Clarus TURBO LED Light Source
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTILamp, Endoscope, Incandescent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTILamp, Endoscope, IncandescentGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971455000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971455000CLARUS MODEL 5197 SIGHTLITEClarus Medical Systems, Inc.1997-05-20FTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B06751972010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intubation light sourceA device designed as a handle containing a light source used to provide cold light illumination for a patient's airways during access, intubation, and airway management. It is a pistol-grip-like device that contains the batteries that provide energy for the airway-illuminating lighting for the attached fibreoptic stylet and an illumination source (e.g., a halogen light bulb). This device is used together with other devices, e.g., stylets, oxygen (O2) connectors, a camera adaptor, typically to manage and document difficult airway intubations. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure60 KiloPascal90 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
High-level Disinfectant

Contacts#

Phone, Email table
PhoneEmail
763-525-8400admin@clarus-medical.com

Regulatory Flags#

DUNS number
010316284
Device count
1
DM exempt
true
Serial number
true
Sterilization required before use
true

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