DEVICE: SPRINT™ (00854001007205)
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Device Identifier (DI) Information
SPRINT™
Short Cable
Not in Commercial Distribution
9191-CME
SPR THERAPEUTICS, INC.
Short Cable
Not in Commercial Distribution
9191-CME
SPR THERAPEUTICS, INC.
SPRINT™ Short Cable
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| NHI | Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -20 and 55 Degrees Celsius |
| Handling Environment Temperature: between -20 and 55 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
30f01bf3-483f-4bd1-aa46-d9021b4badbf
July 24, 2023
8
January 19, 2017
July 24, 2023
8
January 19, 2017
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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
[?]
No Customer Contact currently defined