AccessGUDID - DEVICE: Single-use Extraction Baskets (06971381251647)

GUDID

Device Identifier (DI) Information

Brand Name: Single-use Extraction Baskets
Version or Model: EBT-08
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06971381251647
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544519831 *Terms of Use

Device Description: The product is composed of basket assembly, sheath assembly and handle assembly. This product is intended to capture, manipulate and remove stones and other foreign bodies during urinary diagnosis and treatment under endoscope.

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?
46452	Biliary/urinary stone retrieval basket, single-use	A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFL	Dislodger, Stone, Basket, Ureteral, Metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1dd495f-720d-403d-ace2-29e175f11926
Public Version Date: April 09, 2025
Public Version Number: 3
DI Record Publish Date: May 24, 2023