DEVICE: Verify® External Neurostimulator (00763000344573)
Device Identifier (DI) Information
Verify® External Neurostimulator
353101
In Commercial Distribution
MEDTRONIC, INC.
353101
In Commercial Distribution
MEDTRONIC, INC.
ENS 353101 VERIFY ISTM US EMANUAL
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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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? |
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61392 | Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator |
A portable, external battery-powered component of a sacral plexus percutaneous incontinence-control electrical stimulation system, intended to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via percutaneous electrodes (not included). It may be self-controlled or controlled by a separate external programmer. It is typically used during a trial period (<30days) to validate the therapy.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EZW | Stimulator, electrical, implantable, for incontinence |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P080025 | 142 |
P970004 | 247 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6beed998-6ff7-48ac-ab2b-6cc97c9e57c3
October 05, 2020
1
September 25, 2020
October 05, 2020
1
September 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com