Cadwell

Basic Information

• Brand Name: Cadwell
• Primary DI: 08720791376321
• Version / Model: 302868-000
• Company Name: Technomed Engineering B.V.
• Labeler DUNS: 418415568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-11
• Public Version: 4
• Public Version Date: 2025-02-17
• Public Version Status: Update
• Public Device Record Key: 2cbe3d5e-d44e-46e1-8906-0be13b07cc05

Device Description

Disposable Subdermal Needle Electrode, twisted, 13x0.38mm, 2.0m twisted wire, 20pairs Package DI number: 08720791376277

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IKT	Electrode, Needle, Diagnostic Electromyograph	Physical Medicine	890.1385	2
GXZ	Electrode, Needle	Neurology	882.1350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11441	Electromyographic needle electrode, single-use	A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720791376321	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	13	Millimeter
Outer Diameter	0.38	Millimeter