FDA.reportPublic FDA data

Uvision Hysteroscope Cable

Primary DI
00853277008022
Brand
Uvision Hysteroscope Cable
Company
UVISION 360, INC.
Model
20050
Published
2019-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181909000Luminelle DTx Hysteroscopy SystemUvision360, Inc.2018-08-16FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853277008029PackageGS11In Commercial Distribution
00853277008022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085327700802910853277008029
00853277008022008532770080228532770080220853277008022

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, reusableAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080826327
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853277008107LUMINELLE AspiratorLUM-A200812024-02-29
10853277008104LUMINELLE AspiratorLUM-A200812024-02-29
00853277008084LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 UP200802021-08-13
00853277008091LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 DOWN200852021-08-13
10853277008081LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 UP200802021-08-13
10853277008098LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)LUMBx-360 DOWN200852021-08-13
00853277008060LUMINELLE Dx 360o Rotatable Disposable Sheath (Diagnostic)LUMDx-360200702019-11-07
00853277008053LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
00853277008008LUMINELLE DTx 360 Rotatable Disposable SheathsLUMDTx-360200202019-05-30
00853277008015Uvision HysteroscopeLUMDTx-A1200102019-05-30
00853277008039Luminelle DTx Control Hub200122019-05-30
00853277008046LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30
10853277008050LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
10853227708054LUMINELLE DTx 360 Rigid Rotatable Disposable SheathLUMDTx-360R200602019-06-17
00853227708002LUMINELLE DTx 360 Rotatable Disposable SheathsLUMDTx-360200202019-05-30
00853227708019Uvision HysteroscopeLUMDTx-A1200102019-05-30
00853227708026Uvision Hysteroscope Cable200502019-05-30
00853227708033Luminelle DTx Control Hub200122019-05-30
00853227708040LUMINELLE DTx Hysteroscopy SystemLumDTX-A200302019-05-30

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Primary DI, Brand, Company table
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06972084140610AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
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