AccessGUDID - DEVICE: CONMED (30653405009164)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 60-5103-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-5103-001
Company Name: Conmed Corporation

Primary DI Number: 30653405009164
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ELECTROSURGICAL UNIT FOOTSWITCH

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:	No
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?
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable 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 [?]
K831291	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 Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 158 Degrees Fahrenheit
Handling Environment Temperature: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3cc1d4fd-1110-48e8-8f8b-6ea959bd5e6d
Public Version Date: August 20, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2016