AccessGUDID - DEVICE: Horizon™ (10816843022270)

GUDID

Device Identifier (DI) Information

Brand Name: Horizon™
Version or Model: S91690-50/PK
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ROCHESTER ELECTRO-MEDICAL, INC.

Primary DI Number: 10816843022270
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 068156330 *Terms of Use

Device Description: DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 6 MM NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C

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: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 5fe7c4c7-bed9-4e5e-aa1e-f8496a6b8020
Public Version Date: May 21, 2019
Public Version Number: 3
DI Record Publish Date: September 24, 2016