FDA.reportPublic FDA data

Prosidio

Primary DI
00850042909058
Brand
Prosidio
Company
Prosidio LLC
Model
P417W0011
Catalog number
P417W0011
Device description
0°,_4mm_175mm (110° angle of field) rigid sinuscope
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850042909058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042909058008500429090588500429090580850042909058

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical rhinolaryngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the upper airway structures which include the nasal passages, nasopharynx, oropharynx, and the larynx. It is inserted into the body through a nostril during rhinolaryngoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. The device is subject to viewing limitations due to its rigid design. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
035702151
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850042909003ProsidioP417N00P417N002026-01-16
00850042909010ProsidioP417N30P417N302026-01-16
00850042909812ProsidioP417R30P417R302026-01-16
00850042909027ProsidioP417N45P417N452025-12-05
00850042909034ProsidioP417R45P417R452025-12-05
00850042909041ProsidioP417W0090P417W00902025-12-05
00850042909065ProsidioP417N110P417N1102025-12-05
00850042909072ProsidioP417N12P417N122025-12-05
00850042909089ProsidioP417W3090P417W30902025-12-05
00850042909096ProsidioP417W3011P417W30112025-12-05
00850042909102ProsidioP417W4590P417W45902025-12-05
00850042909119ProsidioP417N70P417N702025-12-05
00850042909126ProsidioP417W7090P417W70902025-12-05
00850042909133ProsidioP417W7011P417W70112025-12-05
00850042909140ProsidioP417N90P417N902025-12-05
00850042909157ProsidioP317N00P317N002025-12-05
00850042909164ProsidioP317N30P317N302025-12-05
00850042909171ProsidioP317N70P317N702025-12-05
00850042909188ProsidioP217N00P217N002025-12-05
00850042909195ProsidioP217N30P217N302025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
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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
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04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
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04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
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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