AccessGUDID - DEVICE: Rhythmlink® (00816312020090)

GUDID

Device Identifier (DI) Information

Brand Name: Rhythmlink®
Version or Model: RLSND113-1.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RHYTHMLINK INTERNATIONAL, LLC

Primary DI Number: 00816312020090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126290993 *Terms of Use

Device Description: 24 electrodes, 19mm long, 0.4mm diameter disposable single subdermal needle with touch proof connector

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?
47714	Subdermal needle electrode	A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXZ	Electrode, Needle

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: Yes
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
Length: 19 Millimeter

Device Record Status

Public Device Record Key: 2d15f4b1-e4b6-4e8a-ae5a-a43fe2ed1b3a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016