DEVICE: SPRINT (00854001007809)

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Device Record History
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Device Identifier (DI) Information
SPRINT
80075
In Commercial Distribution
80075
SPR THERAPEUTICS, INC.
00854001007809
GS1

1
963383778 *Terms of Use
Replacement MicroLead Connector and Key, Dark Channel, Non-Sterile
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Device Characteristics
MR Unsafe
No
Yes
No
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?
60959 Analgesic PENS system
An assembly of mains electricity (AC-powered) devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). It typically consists of external current generator, return electrode(s), connection cables and a system probe which may be provided separately. It is intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve. It is intended to be used by a healthcare professional in a clinical setting.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NHI Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K181422 000
No CLOSE

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

[?]
Storage and Handling
Handling Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Temperature: between -20 and 55 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d51262ae-eb2c-4912-b5e4-29645d8b5afa
January 08, 2021
2
March 06, 2020
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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
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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