AccessGUDID - DEVICE: Power Cord, Autolith Touch, North America (00817183020462)

GUDID

Device Identifier (DI) Information

Brand Name: Power Cord, Autolith Touch, North America
Version or Model: M00546770
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 72-00324-0
Company Name: NORTHGATE TECHNOLOGIES INC.

Primary DI Number: 00817183020462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627969264 *Terms of Use

Device Description: Power cord for use with Autolith Touch Lithotripter, BSC

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:	No
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?
35711	Electrohydraulic lithotripsy system	An assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).	Active	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: No
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: 4ab8d29a-ee9a-449e-b69d-a3a0e39d04cb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 23, 2017