AccessGUDID - DEVICE: CONMED (30653405008143)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 60-0137-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60-0137-001
Company Name: Conmed Corporation

Primary DI Number: 30653405008143
Issuing Agency: GS1
Commercial Distribution End Date: November 18, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: REUSABLE GROUNDING PAD CABLES

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?
63401	Electrosurgical return lead	An insulated metal wire(s) intended to connect an electrosurgical return electrode (not included) to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during monopolar electrosurgery. 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 [?]
K771007	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: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -29 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Temperature: between -20 and 120 Degrees Fahrenheit
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Temperature: between 16 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae265e5c-0524-4dc6-8fbe-9b22e177f1a8
Public Version Date: November 18, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016