AccessGUDID - DEVICE: LITHOCLAST (07613353151843)

GUDID

Device Identifier (DI) Information

Brand Name: LITHOCLAST
Version or Model: B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FR-089#A/001
Company Name: E.M.S. Electro Medical Systems S.A.

Primary DI Number: 07613353151843
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481233849 *Terms of Use

Device Description: Pneumatic handpiece pn3 kit

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?
47098	Pneumatic lithotripsy system handpiece	A hand-held component of a pneumatic intracorporeal lithotripsy system designed to hold the system's ballistic probe (i.e., it forms a handle around the probe) and is connected via a dedicated cable to the system's control unit from which energy is transmitted. The handpiece includes connectors and is typically made of metal [e.g., stainless steel, aluminium (Al)] and plastic materials. It may also facilitate suction used for the removal of the fragmented calculi. This is a reusable device.	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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 5f7e95b4-9c65-4e54-b13c-8e09a7ec4299
Public Version Date: September 15, 2021
Public Version Number: 1
DI Record Publish Date: September 07, 2021