AccessGUDID - DEVICE: CONMED (20653405002465)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 130320
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 130320
Company Name: Conmed Corporation

Primary DI Number: 20653405002465
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 250
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 30653405002462

Device Description: CONMED ELECTROSURGICAL SAFETY HOLSTER, DISPOSABLE

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?
45686	Electrosurgical handpiece/electrode holder, single-use	A device intended to be used to house or fix an active electrosurgical handpiece/pen with its electrode when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. The holder will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). 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 [?]
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: a3a2eb4c-b2cf-493a-912f-8c655ed44771
Public Version Date: August 01, 2024
Public Version Number: 2
DI Record Publish Date: December 01, 2023