AccessGUDID - DEVICE: SIGNASPRAY (10855683006262)

GUDID

Device Identifier (DI) Information

Brand Name: SIGNASPRAY
Version or Model: ELECTRODE SOLUTION AND SKIN PREP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18-25
Company Name: PARKER LABORATORIES INC

Primary DI Number: 10855683006262
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 002449593 *Terms of Use

Device Description: Signaspray Electrode Solution and Skin Prep, 250 ml bottle

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):	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?
11425	Electrode conductive medium	A non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GYB	Media, Electroconductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K780973	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ff2bd59-9a37-423d-88ca-df0d51da8263
Public Version Date: October 22, 2018
Public Version Number: 4
DI Record Publish Date: December 19, 2016