AccessGUDID - DEVICE: Profile Applicator (00812265010300)

GUDID

Device Identifier (DI) Information

Brand Name: Profile Applicator
Version or Model: FLE0104
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sanuwave, Inc.

Primary DI Number: 00812265010300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832217439 *Terms of Use

Device Description: Profile Hand-held Treatment Applicator designed to use with Profile Control Console (PRF100)

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?
59045	Dermatological extracorporeal shock wave therapy system applicator	A hand-held component of a dermatological extracorporeal shock wave therapy (ESWT) system designed to transmit spark-gap-generated (electrohydraulic) shock waves to treat acute and chronic conditions of the skin and subcutaneous soft tissues (e.g., arterial, venous, diabetic or pressure ulcers; burns; traumatic wounds; cellulite). It is connected to the system generator by a flexible conduit and has a fluid-filled head portion intended to be moved over the skin surface of the treatment area for application of the shock waves. It is typically used with a sterile drape during treatment of open wounds and requires a sterile transmission media (ultrasonic gel). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: bfc7db0f-4379-4cae-b9e0-e67d1ac00285
Public Version Date: February 02, 2021
Public Version Number: 1
DI Record Publish Date: January 25, 2021