AccessGUDID - DEVICE: Accordion Piccolo Stone Management Device (00857252004030)

GUDID

Device Identifier (DI) Information

Brand Name: Accordion Piccolo Stone Management Device
Version or Model: PA1205-27-10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: T H S INTERNATIONAL, INC.

Primary DI Number: 00857252004030
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 101084796 *Terms of Use

Device Description: Accordion Piccolo Stone Management Device

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?
60482	Ureteropelvic stone filtering catheter	A flexible tubular device with a non-detachable expandable filter at the distal end intended to be temporarily introduced, via the ureter or percutaneously, into the urinary tract to prevent migration/allow filtration of stone fragments during a lithotripsy procedure. It may also be used for the injection of a contrast medium for fluoroscopic visualization (i.e., retrograde pyelogram), guidance of other devices and/or drainage of fluids. 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: 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: 7f15d6fe-2cf7-4ee6-8db3-c3eb995412be
Public Version Date: January 27, 2020
Public Version Number: 4
DI Record Publish Date: June 01, 2018