Uro-G Flexible Cystoscope

Primary DI
00860008483706
Brand
Uro-G Flexible Cystoscope
Company
UROVIU CORP.
Model
1520
Catalog number
1520
Device description
The Uro-G Flexible Cystoscope System consists of a multi-use handle with an LCD screen and a single-use sterile cannula. The Uro-G Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
Published
2022-12-16
Public version status
New
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
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202921000Uro-G CystoscopeUroviu Corporation2021-05-04FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008483706PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008483706008600084837068600084837060860008483706

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video cystoscope, single-useA sterile 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 single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
650 397 5174cs@uroviu.com

Regulatory Flags#

DUNS number
118239699
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008483713Uro-V Cystoscope101210122022-12-16
00860008483720Uro-N Cystoscope111511152022-12-16

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