AccessGUDID - DEVICE: DUOLITH® (07630039100773)

GUDID

Device Identifier (DI) Information

Brand Name: DUOLITH®
Version or Model: SD1 T-Top
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Storz Medical AG

Primary DI Number: 07630039100773
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 481967776 *Terms of Use

Device Description: Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

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?
47995	Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system	An assembly of devices designed to provide electromechanical orthopaedic extracorporeal shock wave therapy (OEST) and pneumatic pressure wave therapy to treat musculoskeletal disorders. It is typically mobile and includes a control unit that uses both an electrical current and compressed air to create kinetic energy which is transferred to a patient's body upon contact (e.g., with two different hand-held surface applicators) to produce mechanical shock waves at selected amplitudes and frequencies. It is used to treat soft-tissue pain and inflammation near bones, disorders such as tendinopathies and lateral/medial epicondylitis, and to stimulate osteogenesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBN	Generator, Shock-Wave, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080028	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: 0ff3d470-083a-4d3a-9162-898eac6f966c
Public Version Date: September 15, 2023
Public Version Number: 4
DI Record Publish Date: June 27, 2016