FDA.reportPublic FDA data

Prosidio

Primary DI
00860006918705
Brand
Prosidio
Company
Prosidio LLC
Model
L.E. All-in-one endoscopy system V1.0
Catalog number
LE001
Device description
The Prosidio L.E. all-in-one camera system is an all-in-one camera system for rigid and flexible endoscopes.
Published
2021-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWLCamera, Cine, Endoscopic, Without Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWLCamera, Cine, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860006918705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860006918705008600069187058600069187050860006918705

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing/light source systemA mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035702151
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
00840319758977Hayden MedicalHayden Medical, Inc.FWL2026-04-23
08908025548083UnivLabs UNIVLABS TECHNOLOGIES PRIVATE LIMITEDFWL2025-07-01
00840319757963Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757970Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757321Hayden MedicalHayden Medical, Inc.FWL2024-06-27
08800033200048ITS Model-L6KInTheSmart Co., Ltd.FWL2022-11-11
00078301211227Health SupportCarolon CompanyFWL2022-10-18
00851289007224Firefly Firefly GlobalFWL2022-09-20
00857326005567FocESSSTRYKER CORPORATIONFWL2020-09-18
00863333000327DUROSCOPEFMD, LLCFWL2019-02-09
00863333000334DUROSCOPEFMD, LLCFWL2019-02-09
00863333000358DUROSCOPEFMD, LLCFWL2019-02-09
86333300030188DUROSCOPEFMD, LLCFWL2019-02-09
86333300030218DUROSCOPEFMD, LLCFWL2019-02-09
86333300030232DUROSCOPEFMD, LLCFWL2019-02-09
B1778020RF0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-10-18
B1778007I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778008I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778009I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778013I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778019I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778020I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780500Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780520Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
00851289007040RedfinFirefly GlobalFWL2018-08-14
00851289007057FireflyFirefly GlobalFWL2018-08-14
08800033200031ITS Model-LInTheSmart Co., Ltd.FWL2018-06-15
B351MV80000mytaMedMytamed, Inc.FWL2018-02-16
B351MV80010mytaMedMytamed, Inc.FWL2018-02-16