AccessGUDID - DEVICE: Cadwell Disposable Subdermal Needle Electrode (00840067101445)

GUDID

Device Identifier (DI) Information

Brand Name: Cadwell Disposable Subdermal Needle Electrode
Version or Model: 302353-000-080
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CADWELL INDUSTRIES, INC.

Primary DI Number: 00840067101445
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 098554157 *Terms of Use

Device Description: Cadwell Disposable Subdermal Needle Electrode

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":	Yes
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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Meter

Device Record Status

Public Device Record Key: 6edcee15-a5af-41b8-8a3d-86159999d0ae
Public Version Date: January 09, 2024
Public Version Number: 3
DI Record Publish Date: September 05, 2016