FDA.reportPublic FDA data

Prosidio

Primary DI
00860006918781
Brand
Prosidio
Company
Prosidio LLC
Model
P317R45
Catalog number
P317R45
Device description
HiFi rigid sinuscope, 45°, 3 mm diameter x 175 mm working length, reverse light post.
Published
2026-10-24
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

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
00860006918781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006918781008600069187818600069187810860006918781

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
00860006918774ProsidioP317R30P317R302026-10-24
00860006918798ProsidioP317R70P317R702026-10-24
00850042909003ProsidioP417N00P417N002026-01-16
00850042909010ProsidioP417N30P417N302026-01-16
00850042909812ProsidioP417R30P417R302026-01-16
00850042909027ProsidioP417N45P417N452025-12-05
00850042909034ProsidioP417R45P417R452025-12-05
00850042909041ProsidioP417W0090P417W00902025-12-05
00850042909058ProsidioP417W0011P417W00112025-12-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860006918774ProsidioProsidio LLCEOB2026-10-24
00860006918798ProsidioProsidio LLCEOB2026-10-24
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