DEVICE: Lamitrode™ (05414734406222)

Device Identifier (DI) Information

Lamitrode™
3245
In Commercial Distribution
3245
ST. JUDE MEDICAL, INC.
05414734406222
GS1

1
149818952 *Terms of Use
44C Lead Kit, 60cm Length
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62423 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection
An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LGW STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P010032 010
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
Storage Environment Temperature: between 14 and 131 Degrees Fahrenheit
Handling Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Temperature: between 14 and 131 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 150 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 150 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
Length: 60 Centimeter
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Device Record Status

ce7c69f2-1472-4c1e-b313-eb5cf0531976
August 15, 2023
4
March 11, 2015
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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
No
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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