AccessGUDID - DEVICE: HELIXAR (00653405001976)

GUDID

Device Identifier (DI) Information

Brand Name: HELIXAR
Version or Model: 60-8480-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-8480-001
Company Name: Conmed Corporation

Primary DI Number: 00653405001976
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: HELIXAR WIRELESS FOOTSWITCH KIT

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):	No
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?
44774	Inert gas-enhanced electrosurgical system	An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of an inert gas [e.g., argon (Ar), helium (He)] during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and a gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the gas shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152860	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
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Humidity: between 5 and 60 Percent (%) Relative Humidity
Handling Environment Temperature: between 100 and 131 Degrees Fahrenheit
Handling Environment Temperature: between -29 and 38 Degrees Celsius
Handling Environment Temperature: between -20 and 100 Degrees Fahrenheit
Handling Environment Humidity: less than 20 Percent (%) Relative Humidity
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Temperature: between 38 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a3730ab-ff1c-4baf-a730-df99a71b6424
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016