FDA.reportPublic FDA data

Prosidio

Primary DI
00850042909515
Brand
Prosidio
Company
Prosidio LLC
Model
P818H70
Catalog number
P818H70
Device description
70°, 8mm 185mm rigid laryngoscope with handle
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
ERAOtoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850042909515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850042909515008500429095158500429095150850042909515

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
Premarket exempt
true
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
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
00850042909171ProsidioP317N70P317N702025-12-05
00850042909188ProsidioP217N00P217N002025-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
16972545090017JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
16972545090031JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-05-18
00050428029497CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDERA2026-02-13
KTS0025716K.T.SurgicoK.T.SURGICOERA2024-07-24
00311917035000WalgreensWALGREEN CO.ERA2023-11-01
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.ERA2023-10-15
10884389104514MedlineMEDLINE INDUSTRIES, INC.ERA2023-01-21