AccessGUDID - DEVICE: SOFTRACE (10653405052920)

GUDID

Device Identifier (DI) Information

Brand Name: SOFTRACE
Version or Model: 2350-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 2350-003
Company Name: Conmed Corporation

Primary DI Number: 10653405052920
Issuing Agency: GS1
Commercial Distribution End Date: March 27, 2023
Device Count: 300
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SOFTRACE REPOSITIONABLE,LG,3

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?
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991105	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 Temperature: between -4 and 131 Degrees Fahrenheit
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius
Handling Environment Humidity: less than 85 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 95 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0d98e51-96da-443c-ad09-91ef3a87e4b5
Public Version Date: March 27, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016