AccessGUDID - DEVICE: HOTSY (00893398002530)

GUDID

Device Identifier (DI) Information

Brand Name: HOTSY
Version or Model: Cautery High Temperature Fine Tip
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 20-HM-2000
Company Name: SHIPPERT MEDICAL TECHNOLOGIES, INC

Primary DI Number: 00893398002530
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 051437143 *Terms of Use

Device Description: Disposable High-Temperature (2000° C) Fine Tip Cautery battery operated with batteries installed. Unit has a four year shelf life.

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:	Yes
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?
45631	Electrocautery system handpiece	An electrode handpiece that functions as the holder for a detachable cautery electrode, which together become the conducting unit, providing a means of conducting an electrical current used to heat the electrode tip used during surgical intervention to burn or sear body tissue. It will typically be made of heat and electrical resistant materials and include the cables/plugs that connect to the generator. This device can be used for, e.g., to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQP	Unit, Cautery, Thermal, Battery-Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
Device Size Text, specify: Fine Tip

Device Record Status

Public Device Record Key: 9b7b4725-5d55-4e2a-9865-e68c4e7b607c
Public Version Date: May 08, 2023
Public Version Number: 5
DI Record Publish Date: August 12, 2016