DEVICE: Paired VNS (10810041430080)

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Device Record History
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Device Identifier (DI) Information
Paired VNS
3000
In Commercial Distribution

Microtransponder
10810041430080
GS1

1
793502068 *Terms of Use
Lead, 3 mm cuff
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Device Characteristics
MR Conditional
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?
44041 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).
Active true
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FDA Product Code

[?]
Product Code Product Code Name
QPY Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
P210007 000
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b0525b98-27ea-4e4a-a3c2-40b29b34aa0e
May 09, 2022
1
April 29, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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