AccessGUDID - DEVICE: LithoClast (07613353000332)

GUDID

Device Identifier (DI) Information

Brand Name: LithoClast
Version or Model: DT-059
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M0068407500
Company Name: E.M.S. Electro Medical Systems S.A.

Primary DI Number: 07613353000332
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 481233849 *Terms of Use

Device Description: Stone catcher - sterile

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?
47464	Intracorporeal lithotripsy suction system	An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. It typically consists of a pneumatically-powered pump that creates suction via the venturi mechanism, a vacuum gauge, vacuum control knob, a compressed air connector, tubing, a moisture filter, and possibly a microbial filter. The vacuum created by the pump is applied to the body through the tubing and an inserted probe, for the removal of the calculi in a stone catcher and the fluid in a collection container.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, Electro-Hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963285	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: d5a4c0ec-0029-402c-8630-3473f4627f2f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016