AccessGUDID - DEVICE: Sterile electrode's cable (07290014954953)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile electrode's cable
Version or Model: Sterile Neuro Omega AlphaProbe electrode's cable 10 CH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: STR-000664-21
Company Name: ALPHA OMEGA ENGINEERING CO. LTD.

Primary DI Number: 07290014954953
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 531856466 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
32556	Depth electrode	An electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZL	Electrode, Depth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120098	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 252ce7d6-5305-4a5e-9526-0ae860211103
Public Version Date: January 01, 2024
Public Version Number: 6
DI Record Publish Date: March 19, 2018