AccessGUDID - DEVICE: 24K (20845854041175)

GUDID

Device Identifier (DI) Information

Brand Name: 24K
Version or Model: 24K900
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 24K900
Company Name: Conmed Corporation

Primary DI Number: 20845854041175
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: 24K SHAVER SENSOR

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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRX	ARTHROSCOPE

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Dry
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cbf21f82-8ea3-4fa4-8519-c1d72c9e5075
Public Version Date: November 29, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016