AccessGUDID - DEVICE: CONMED (30653405014380)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 714-S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 714-S
Company Name: Conmed Corporation

Primary DI Number: 30653405014380
Issuing Agency: GS1
Commercial Distribution End Date: December 06, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: EPILATION/TELANGIECTASIAS NEEDLE STEALTH ER COATING 30 DEGREE ANGLE, 3/8 Inch NEEDLE 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:	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?
61876	Open-surgery electrosurgical electrode, monopolar, reusable	An invasive, monopolar, electrical conductor intended to be attached to an electrosurgical 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 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 [?]
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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -34 and 65 Degrees Celsius
Storage Environment Temperature: between 10 and 32 Degrees Celsius
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
Angle: 30 degree
Outer Diameter: 0.375 Inch

Device Record Status

Public Device Record Key: bbe77330-a1f5-408f-affc-ac7320741666
Public Version Date: August 21, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016