AccessGUDID - DEVICE: Single-use Extraction Baskets (06971381252934)

GUDID

Device Identifier (DI) Information

Brand Name: Single-use Extraction Baskets
Version or Model: EBF-2007C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Primary DI Number: 06971381252934
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 for the endoscopic removal of stones and stone fragments in the biliary system.

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?
44333	Urinary stone retrieval basket, single-use	A manual endotherapy instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate urinary stones for the treatment of conditions such as nephrolithiasis and urolithiasis (i.e., presence of calculi in the kidneys or urinary tract). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is used with a nephroscope or ureteroscope during urological and related procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQR	Dislodger, Stone, Biliary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240192	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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Temperature: between -40 and 55 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9516c783-1408-4255-90ac-84ec987f8779
Public Version Date: December 16, 2024
Public Version Number: 1
DI Record Publish Date: December 06, 2024