AccessGUDID - DEVICE: Cadwell (08720791376192)

GUDID

Device Identifier (DI) Information

Brand Name: Cadwell
Version or Model: 302875-000-GP2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Technomed Engineering B.V.

Primary DI Number: 08720791376192
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 418415568 *Terms of Use

Device Description: Disposable Subdermal Needle Electrode, parallel; 14x0.38mm, 2.5m wire parallel, 12pairs Package DI number: 08720791376284

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?
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
IKT	Electrode, Needle, Diagnostic Electromyograph

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: 14 Millimeter
Outer Diameter: 0.38 Millimeter
Needle Gauge: 27 Gauge

Device Record Status

Public Device Record Key: 636cce26-5ec0-45d2-a6d7-1852ee4a2663
Public Version Date: February 17, 2025
Public Version Number: 4
DI Record Publish Date: October 11, 2024