DEVICE: Cadwell (08720791376192)
Device Identifier (DI) Information
Cadwell
302875-000-GP2
In Commercial Distribution
Technomed Engineering B.V.
302875-000-GP2
In Commercial Distribution
Technomed Engineering B.V.
Disposable Subdermal Needle Electrode, parallel; 14x0.38mm, 2.5m wire parallel, 12pairs
Package DI number: 08720791376284
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
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
636cce26-5ec0-45d2-a6d7-1852ee4a2663
February 17, 2025
4
October 11, 2024
February 17, 2025
4
October 11, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+31434086868
info@technomed.nl
info@technomed.nl