AccessGUDID - DEVICE: Adult Dispersive Electrode (00685447001027)

GUDID

Device Identifier (DI) Information

Brand Name: Adult Dispersive Electrode
Version or Model: RFA-GP-BAY
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Baylis Médicale Cie Inc

Primary DI Number: 00685447001027
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 249225954 *Terms of Use

Device Description: Suggested weight: >15kg

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
JOS	Electrode, Electrosurgical
GEI	Electrosurgical, Cutting & Coagulation & Accessories

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: 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: d4f171c6-dfc2-4f77-83a2-d2490960ffd9
Public Version Date: April 11, 2025
Public Version Number: 5
DI Record Publish Date: February 03, 2017