FDA.reportPublic FDA data

ViewHub®

Primary DI
16975339626164
Brand
ViewHub®
Company
MacroLux Medical Technology Co., Ltd.
Model
S13
Device description
ViewHub®, Video Processor, S13
Published
2024-03-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K231774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231774000CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR)MacroLux Medical Technology Co., Ltd.2024-01-11FGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975339626164PackageGS11In Commercial Distribution
26975339626161PackageGS11In Commercial Distribution
06975339626167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697533962616416975339626164
2697533962616126975339626161
06975339626167069753396261676975339626167

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
723490133
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975339620318CoralView®U10-B2024-03-12
06975339620325CoralView®U10-BR2024-03-12
06975339620332CoralView®U202024-03-28
06975339620349CoralView®U20-B2024-03-28
06975339620356CoralView®U20-BR2024-03-28
06975339621179BubbleView®C50-C2024-07-10
06975339621186BubbleView®C50-CR2024-07-10
06975339621193BubbleView®C50-CB2024-07-10
06975339621209BubbleView®C50-CBR2024-07-10
06975339623173SeleneView®HC29-G2024-08-23
06975339623180SeleneView®HC352024-08-23
06975339623197SeleneView®HC35-G2024-08-23
06975339623203SeleneView®HO352024-08-23
06975339623210SeleneView®HO35-G2024-08-23
06975339623227SeleneView®HO422024-08-23
06975339623234SeleneView®HO42-G2024-08-23
06975339627560CoralWellNS-0835B2025-08-10
06975339627577CoralWellNS-0840B2025-08-10
06975339627584CoralWellNS-0845B2025-08-10
06975339627591CoralWellNS-0855B2025-08-10

Other Devices Sharing Product Codes#

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