AccessGUDID - DEVICE: US-LITHO (04055207023211)

GUDID

Device Identifier (DI) Information

Brand Name: US-LITHO
Version or Model: 8963535
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8963.535
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207023211
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: SONOTRODE Ø 3.5MM WL 358MM exchangeable, reusable

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35712	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFK	Lithotriptor, electro-hydraulic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Length: 358 Millimeter
Outer Diameter: 3.5 Millimeter

Device Record Status

Public Device Record Key: a4453569-52ab-4a29-bbe0-4a91da24f6a7
Public Version Date: February 29, 2024
Public Version Number: 7
DI Record Publish Date: September 23, 2016