DEVICE: SPRINT (00854001007489)
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Device Identifier (DI) Information
SPRINT
Sales Box, Lead Tray, Sterile
Not in Commercial Distribution
80042
SPR THERAPEUTICS, INC.
Sales Box, Lead Tray, Sterile
Not in Commercial Distribution
80042
SPR THERAPEUTICS, INC.
Sales Box, Lead Tray, Sterile
Device Characteristics
| MR Unsafe | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| Yes | |
| 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, Electrical, 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
e4f41a2a-5c1c-4063-9d55-9f69d30bcee7
July 24, 2023
4
September 14, 2018
July 24, 2023
4
September 14, 2018
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