AccessGUDID - DEVICE: Dolphin Neurostim (00628176737003)

GUDID

Device Identifier (DI) Information

Brand Name: Dolphin Neurostim
Version or Model: Classic
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Center For Pain and Stress Research Ltd

Primary DI Number: 00628176737003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251050084 *Terms of Use

Device Description: The Dolphin Neurostim Classic is the latest and most scientifically advanced point stimulator on the market. Features an easy-to-use point locator and 600% more power than leading our competitors. Dolphin Point stimulation may be applied with either left or right hands or using an extension probe, grounding pads, or ear clips. Other standard accessories include a 9-volt battery, carrying case, and instruction manual.

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):	Yes
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?
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023726	000
K133789	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: a10156fd-ed7b-4272-8092-cc1bb53a555b
Public Version Date: September 24, 2021
Public Version Number: 1
DI Record Publish Date: September 16, 2021