AccessGUDID - DEVICE: Uretero1 (00724995209162)

GUDID

Device Identifier (DI) Information

Brand Name: Uretero1
Version or Model: UROSD101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UROSD101
Company Name: BLACK DIAMOND VIDEO, INC.

Primary DI Number: 00724995209162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556373053 *Terms of Use

Device Description: The Uretero1 Standard Deflection Disposable Ureteroscope is a single use flexible ureteroscope that is used to visualize and perform various diagnostic and therapeutic procedures in the urinary tract.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64074	Flexible video ureteroscope, single-use	An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are typically transmitted by a video system with a high definition complementary metal oxide semiconductor (CMOS) chip at the distal end with images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGB	Ureteroscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211347	000
K223466	000
K231878	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Length: 230 Centimeter
Outer Diameter: 2.4 Millimeter
Width: 3 Centimeter

Device Record Status

Public Device Record Key: e870ee9e-dde0-4d15-b453-1c1da0c69dec
Public Version Date: August 25, 2025
Public Version Number: 5
DI Record Publish Date: June 10, 2022