AccessGUDID - DEVICE: CONMED (30653405010245)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 60-5181-101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-5181-101
Company Name: Conmed Corporation

Primary DI Number: 30653405010245
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2022
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: CONMED ELECTROSURGICAL ACCESSORY, BALL ELECTRODE, 2MM, EXTENDED SHAFT

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?
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HGI	ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913213	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Handling Environment Humidity: between 5 and 50 Percent (%) Relative Humidity
Handling Environment Temperature: between -29 and 149 Degrees Fahrenheit
Storage Environment Humidity: between 5 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Ball Electrode

Device Record Status

Public Device Record Key: 209ae4b0-ddcb-4425-a80b-18b2c472c827
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: September 24, 2016