DEVICE: VNS Therapy® PerenniaDURA® Model 303 Lead (05425025750115)

Download: XML | JSON

Device Identifier (DI) Information

VNS Therapy® PerenniaDURA® Model 303 Lead
303-20

LIVANOVA USA, INC.
05425025750115
GS1
1
Implantable Lead
CLOSE

Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vagus nerve electrical stimulation system lead An implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MUZ Stimulator, Autonomic Nerve, Implanted (Depression)
LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 55 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 2.0 Millimeter
CLOSE

Device Status

In Commercial Distribution
September 17, 2014

CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
1 (866) 882-8804
ClinicalTechnicalServices@cyberonics.com
CLOSE