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
00810024672011CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-42DS5D200-422026-08-04
00810024672028CPS Locator 3D Plus, Large Delivery CatheterDS5D300-42DS5D300-422026-08-04
00810024672035CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-42DS5D400-422026-08-04
00810024672042CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-45DS5D200-452026-08-04
00810024672059CPS Locator 3D Plus, Large Delivery CatheterDS5D300-45DS5D300-452026-08-04
00810024672066CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-45DS5D400-452026-08-04
00810024672196CPS Locator 3D Plus, Medium Delivery CatheterDS5D200-48DS5D200-482026-08-04
00810024672202CPS Locator 3D Plus, Large Delivery CatheterDS5D300-48DS5D300-482026-08-04
00810024672219CPS Locator 3D Plus, Extra Large Delivery CatheterDS5D400-48DS5D400-482026-08-04
00810024672554AuST Steerable SheathADS-MD-0029572026-08-06
00810024672561AuST Steerable SheathADS-MD-0029582026-08-06
00810024672578AuST Steerable SheathADS-MD-0029592026-08-06
00810024672585AuST Steerable SheathADS-MD-0029602026-08-06
00810024672592AuST Steerable SheathADS-MD-0029612026-08-06
00810024672608AuST Steerable SheathADS-MD-0029622026-08-06
00810024672615AuST Steerable SheathADS-MD-0029632026-08-06
00810024672622AuST Steerable SheathADS-MD-0029642026-08-06
00810024672639AuST Steerable SheathADS-MD-0029652026-08-06
00810024672646AuST Steerable SheathADS-MD-0029662026-08-06
00810024672653AuST Steerable SheathADS-MD-0029672026-08-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FGB2026-08-14
00850023925602WiScope®Otu Medical Inc.FGB2026-07-28
00850023925619WiScope®Otu Medical Inc.FGB2026-07-28
00850023925626WiScope®Otu Medical Inc.FGB2026-07-28
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00850023925978AptraOtu Medical Inc.FGB2026-07-28
06972084140429AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140443AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140450WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
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06972084140542WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
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06972084140566WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140573WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140580WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140702WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28
06972084140719WiScope®Ningbo Wise Optomech Technology CorporationFGB2026-07-28