AccessGUDID - DEVICE: EU-Scope (06970034210345)

GUDID

Device Identifier (DI) Information

Brand Name: EU-Scope
Version or Model: US31B-12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Shanghai AnQing Medical Instrument Co., Ltd

Primary DI Number: 06970034210345
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 544581269 *Terms of Use

Device Description: Flexible Ureterorenoscope is a flexible inserted portion intended for visual examination and treatment of the ureter. Only be used with the designed DOSTM video processor approved by SHANGHAI ANQING.

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":	No
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?
38689	Flexible video ureteroscope, reusable	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 transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the 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 reusable 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 [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f744e140-6da3-43dc-8164-624c282a1509
Public Version Date: October 17, 2022
Public Version Number: 5
DI Record Publish Date: January 10, 2019