FDA.reportPublic FDA data

ACCLARENT CYCLOPS

Primary DI
10705031135666
Brand
ACCLARENT CYCLOPS
Company
ACCLARENT, INC.
Model
CYE002R
Catalog number
CYE002R
Device description
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE - REFURBISHED
Published
2016-09-01
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
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705031135666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503113566610705031135666

GMDN Terms#

Term, Definition table
TermDefinition
Rigid nasopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, clean and safe place at room temperature, in its polypropylene wrap

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Hydrogen Peroxide""]"
Moist Heat or Steam Sterilization;High-level Disinfectant;Hydrogen Peroxide

Contacts#

Phone, Email table
PhoneEmail
+1(650)687-5888xx@xx.xx
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
361092450
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
10705031063297INSPIRA AIRBC1040ABC1040A2016-09-01
10705031063310INSPIRA AIRBC1440ABC1440A2016-09-01
10705031131996INSPIRA AIRBC0524ABC0524A2016-09-01
10705031132061INSPIRA AIRBC0724ABC0724A2016-09-01
10705031147737INSPIRA AIRBC1240ABC1240A2016-09-01
10705031147744INSPIRA AIRBC1640ABC1640A2016-09-01
10705031206052INSPIRA AIRBC8524ABC8524A2016-09-01
20705031063089INSPIRA AIRBC0524AZBC0524AZ2016-09-01
20705031063126INSPIRA AIRBC0724AZBC0724AZ2016-09-01
20705031063157INSPIRA AIRBC1040AZBC1040AZ2016-09-01
20705031063171INSPIRA AIRBC1440AZBC1440AZ2016-09-01
20705031147703INSPIRA AIRBC1240AZBC1240AZ2018-03-31
20705031242682INSPIRA AIRBC8524AZBC8524AZ2018-03-31
10705031245853TruDi NAV CableTDNC001TDNC0012018-10-31
10705031245877TruDi NAV SuctionTDNS000ZTDNS000Z2019-01-20
10705031245884TruDi NAV SuctionTDNS070ZTDNS070Z2019-01-20
10705031245891TruDi NAV SuctionTDNS090ZTDNS090Z2019-01-20
20705031245867TruDi NAV CableTDNC001ZTDNC001Z2018-10-31
10705031200258RELIEVA ULTIRRABC0516RUBC0516RU2016-10-01
10705031200272RELIEVA ULTIRRABC0616RUBC0616RU2016-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921001PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921063PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921070PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921117PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921148PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922473PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922497PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925979PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926358PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926433PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927034PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927041PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826928710PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25
04961333256181PENTAXHOYA CORPORATIONEOB2026-08-25
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16