AccessGUDID - DEVICE: MASTERPULS® (07630039101169)

GUDID

Device Identifier (DI) Information

Brand Name: MASTERPULS®
Version or Model: ONE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Storz Medical AG

Primary DI Number: 07630039101169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481967776 *Terms of Use

Device Description: The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator.

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?
47979	Pressure-wave skin contouring system	An assembly of devices using extracorporeal pulse activation technology (EPAT) and designed for acoustic wave treatment (AWT) intended primarily to reduce the appearance of cellulite through mobilization of free fatty acids and oxidative agents in tissue. It typically consists of a control unit that produces pneumatically-generated and/or electrically-generated pressure waves at selected impulse frequencies by means of one or more hand-held, skin-surface applicators. The system may also be used to treat the skin, e.g., by smoothing wrinkles, tightening muscle/connective tissue, and/or improving lymphatic drainage; it may also be used to treat minor muscle pain.	Active	false
36560	Hand-held electric massager	An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173692	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: 05d4dce4-3b7f-483c-9858-ff43d0ff1003
Public Version Date: August 20, 2020
Public Version Number: 2
DI Record Publish Date: September 16, 2019