AccessGUDID - DEVICE: Spinal Electrode Kit (00841823100818)

GUDID

Device Identifier (DI) Information

Brand Name: Spinal Electrode Kit
Version or Model: CEDL-4PDINX-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CEDL-4PDINX-100
Company Name: Ad-Tech Medical Instrument Corporation

Primary DI Number: 00841823100818
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 174813410 *Terms of Use

Device Description: No description.

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
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE
GZL	ELECTRODE, DEPTH
JXE	DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973454	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
Special Storage Condition, Specify: To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 737762d3-cf1b-4464-8716-8a42c2cdf1df
Public Version Date: August 23, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016