AccessGUDID - DEVICE: Accu-temp (30886158010235)

GUDID

Device Identifier (DI) Information

Brand Name: Accu-temp
Version or Model: 8440000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8440000
Company Name: Beaver-Visitec International, Inc.

Primary DI Number: 30886158010235
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 001406024 *Terms of Use

Device Description: ACCU-TEMP® CAUTERY VARIABLE LOW TEMP 0.5 FINE TIP 10/BX

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?
35029	Electrocautery system generator, battery-powered	A battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.	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
No Device Sizes

Device Record Status

Public Device Record Key: 357c2ecb-1e97-45e9-8a7c-32b113920e5c
Public Version Date: January 27, 2022
Public Version Number: 1
DI Record Publish Date: January 19, 2022