AccessGUDID - DEVICE: THERMOGARD (10653405013747)

GUDID

Device Identifier (DI) Information

Brand Name: THERMOGARD
Version or Model: 7-382
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7-382
Company Name: Conmed Corporation

Primary DI Number: 10653405013747
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2023
Device Count: 40
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: THERMOGARD PLUS ABC DUAL DISPERSIVE ELECTRODE

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?
58494	Electrosurgical return electrode, single-use	A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140658	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
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Handling Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78db9141-40b5-4d58-b073-5469eea2c8f7
Public Version Date: January 11, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016