DEVICE: NA (05414734402309)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
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65308 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead extension |
An implantable device intended to extend the electrical connection between a spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator and a lead(s). It typically includes small connectors to enable attachment to the lead(s) and pulse generator, and a length of insulated wire; the lead(s) and pulse generator are not included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GZB | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K032751 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 60 Centimeter |
Device Record Status
535bba9d-1c7f-495b-99ff-35e2116ee62d
February 10, 2022
5
April 25, 2015
February 10, 2022
5
April 25, 2015
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(855)478-5833
customerservice@sjm.com
customerservice@sjm.com