FDA.reportPublic FDA data

RenaNav Video Processing Unit

Primary DI
00810024670376
Brand
RenaNav Video Processing Unit
Company
CENTERPOINT SYSTEMS LLC
Model
NVS-MD-000386
Device description
Video processing unit for RenaNav Single-Use Digital Flexible Ureteroscope
Published
2024-04-15
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
FGBUreteroscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGBUreteroscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223097000RenaNav Ureteroscope SystemCenterPoint Systems, LLC2023-07-31FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810024670376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810024670376008100246703768100246703760810024670376

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117126091
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810024672134CPS Locator 3D, BB1-36DS2CBB1-36DS2CBB1-362026-03-30
00810024672141CPS Locator 3D, BB1-40DS2CBB1-40DS2CBB1-402026-03-30
00810024671991AuST Steerable Sheath0-132H-H3574SAN0-SNSP02026-01-29
00810024672004AuST Steerable Sheath0-132H-H5074SAN0-SNSP02026-01-29
00810024670314AuST Steerable Sheath0-120H-H1774SAN5-SNSP02026-01-12
00810024670536AuST Steerable Sheath0-085H-H1774SAN0-SNSP02026-01-12
00810024670543AuST Steerable Sheath0-085H-H2274SAN0-SNSP02026-01-12
00810024670550AuST Steerable Sheath0-085H-H5074SAN0-SNSP02026-01-12
00810024671724DF4 Helix Locking ToolA002HELX2025-12-03
00810024671342AuST Steerable Sheath0-085H-H1744SAN0-SNSP02025-11-05
00810024671359AuST Steerable Sheath0-085H-H2244SAN0-SNSP02025-11-05
00810024671366AuST Steerable Sheath0-085H-H3544SAN0-SNSP02025-11-05
00810024671373AuST Steerable Sheath0-085H-H5044SAN0-SNSP02025-11-05
00810024671380AuST Steerable Sheath0-132H-H3544SAN0-SNSP02025-11-05
00810024671397AuST Steerable Sheath0-132H-H5044SAN0-SNSP02025-11-05
00810024671403AuST Steerable Sheath0-085H-S1765SAN0-SNSP02025-11-05
00810024671410AuST Steerable Sheath0-120H-H1765SAN0-SNSP02025-11-05
00810024671427AuST Steerable Sheath0-120H-H2265SAN0-SNSP02025-11-05
00810024671434AuST Steerable Sheath0-120H-H3565SAN0-SNSP02025-11-05
00810024671441AuST Steerable Sheath0-132H-H3565SAN0-SNSP02025-11-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.FGB2026-05-22
00810116023387Dornier Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023400Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
00810116023578Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-05-06
10810068811046MONARCH™Platform, UrologyAuris Health, Inc.FGB2026-05-05
10810068811053Monarch® Ureteroscopy KitAuris Health, Inc.FGB2026-05-05
10810068811107MONARCH™ Urology Irrigation CartridgeAuris Health, Inc.FGB2026-05-04
10810068811121MONARCH™ Ureteroscope ValveAuris Health, Inc.FGB2026-05-04
00810116024056Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024070Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024094Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
00810116024117Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-03-26
06972520301216Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301223Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301230Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301247Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301254Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301261Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301278Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
06972520301285Ascend™ Single-Use Flexible UreteroscopeGuangzhou Red Pine Medical Instrument Co., Ltd.FGB2026-03-17
00810116023370Dornier MedTech DORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023417Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023523Axis IIDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
00810116023585Dornier MedTechDORNIER MEDTECH AMERICA, INC.FGB2026-01-22
06971176282924Single Use Video Ureteroscope Direct In-Scope SuctionZhuhai Pusen Medical Technology Co, LtdFGB2026-01-13