AccessGUDID - DEVICE: Wellead Stone Retrieval Basket (06936881139383)

GUDID

Device Identifier (DI) Information

Brand Name: Wellead Stone Retrieval Basket
Version or Model: U04B011010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Well Lead Medical Co.,Ltd

Primary DI Number: 06936881139383
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544811862 *Terms of Use

Device Description: SB3NS-17130-8

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
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a368755e-f3e8-4794-b602-b70168d1f956
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023