AccessGUDID - DEVICE: US-LITHO (04055207012161)

GUDID

Device Identifier (DI) Information

Brand Name: US-LITHO
Version or Model: 2271501
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2271.501
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207012161
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: TRANSDUCER Ø 28.5MM WL 145MM

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Ultrasonic lithotripsy system	An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. This system can have a variety of configurations and will typically employ endoscopic devices together with a dedicated US transducer and probe (e.g., a sonotrode) during its application. The debris may be forcefully removed (e.g., through irrigation/suction) or passed out by natural means at a later date.

GMDN Preferred Term Name

GMDN Definition

Ultrasonic lithotripsy system

An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. This system can have a variety of configurations and will typically employ endoscopic devices together with a dedicated US transducer and probe (e.g., a sonotrode) during its application. The debris may be forcefully removed (e.g., through irrigation/suction) or passed out by natural means at a later date.

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, electro-hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011065	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
Length: 145 Millimeter
Outer Diameter: 28.5 Millimeter

Device Record Status

Public Device Record Key: 072cf26f-c137-4d28-90b3-20743aa42488
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 21, 2017