AccessGUDID - DEVICE: Sting Doctor (00850018026109)

GUDID

Device Identifier (DI) Information

Brand Name: Sting Doctor
Version or Model: SD-MC6
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Spark Innovators Corporation

Primary DI Number: 00850018026109
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 831838391 *Terms of Use

Device Description: The Sting Doctor is a handheld, battery powered device that uses targeted heat therapy intended to help reduce the itch and irritation caused by insect bites/stings from mosquitoes, bees, and wasps.

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):	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?
47103	Insect bite/sting hyperthermia device	A portable, electrically-powered device intended to be used for the external surface treatment of insect bites or stings (e.g., from midges/gnats, mosquitoes, wasps, hornets, horseflies) through the topical application of concentrated heat. The heat (around 50° Celsius) works to minimize or prevent itching, and may prevent subsequent swelling. It may be either a self-contained hand-held unit or an attachment for a smartphone. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

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: 2eeb62e6-b735-44d6-8717-3dfc0f301714
Public Version Date: August 09, 2021
Public Version Number: 2
DI Record Publish Date: January 20, 2021