AccessGUDID - DEVICE: Lithotripsy Probe 1.9FR 120cm (00817183020103)

GUDID

Device Identifier (DI) Information

Brand Name: Lithotripsy Probe 1.9FR 120cm
Version or Model: 9-203-1203
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NORTHGATE TECHNOLOGIES INC.

Primary DI Number: 00817183020103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627969264 *Terms of Use

Device Description: 1.9FR 120cm Lithotripsy Probe for use with Autolith Uro-Touch Lithotripters

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):	Yes
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?
60461	Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-use	A sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. It is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. It may be introduced endoscopically through a natural body orifice or a surgically made opening. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, Electro-Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130368	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 05656851-6efc-42ae-9881-716bf58bad05
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 13, 2016