FDA.reportPublic FDA data

Vision1

Primary DI
00724995209186
Brand
Vision1
Company
BLACK DIAMOND VIDEO, INC.
Model
VIS101
Catalog number
VIS101
Device description
The Vision1 Imaging Console and Display System is used exclusively with the Uretero1 Ureteroscope System.
Published
2022-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K211347000
K223466000
K231878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211347000Uretero1 Ureteroscope SystemSTERIS Corporation2021-11-23FGB
K223466000Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101STERIS Corporation2023-02-17FGB
K231878000Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101STERIS Corporation2023-07-25FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995209186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995209186007249952091867249952091860724995209186

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display monitorA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a flexible video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length230Centimeter
Outer Diameter2.4Millimeter
Width3Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
556373053
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995245054HexaVueHexaVue FocusXEHFSLC2025-10-17
00724995245061HexaVueHexaVue FocusXEHFSLCAMC2025-10-17
00724995220587HexaVueHexaVue IPXQHPSLC2024-02-08
00724995220594HexaVueHexaVue IPXQHPILCC2024-02-08
00724995198503HexaVueHexaVue SCC 1.0XQHILCC12021-03-31
00724995198497HexaVueHexaVue-SLC 1.0XQHLC12020-09-04
00724995198459FREE5Free5 CameraRLQ1080FCS2021-04-23
00724995209162Uretero1UROSD101UROSD1012022-06-10
00724995209179Uretero1URORD101URORD1012022-06-10
00724995198473NAIDSS-SCCXQSILCC12021-04-23
00724995199135Harmony iQHarmony iQ 2800RLQ2000SLC2021-04-23
00724995199142Harmony iQHarmony iQ 3600RLQ3600SLC2021-04-23
00724995163723NAIDSS-SLC Version 8XQSLC12019-02-28
00724995153083NAIDSS-SLCXQSLC12017-06-06
00724995218799Vividimage W 4KRLM65MG4K3RLM65MG4K32022-08-19
00724995195113Vividimage 4KRLM314K3RLM314K32021-04-23
00724995195137Vividimage 4KRLM314K3NPWRRLM314K3NPWR2021-04-23
00724995195069Vividimage D HDRLM27HD3RLM27HD32021-03-31
00724995195090Vividimage D HDRLM27HD3NPWRRLM27HD3NPWR2021-03-31
00724995195106Vividimage 4KRLM314K2RLM314K22021-03-31

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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
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00850023925657WiScope®Otu Medical Inc.FGB2026-07-28
00850023925978AptraOtu Medical Inc.FGB2026-07-28
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06972084140436AptraNingbo Wise Optomech Technology CorporationFGB2026-07-28
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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