FDA.reportPublic FDA data

SPRINT

Primary DI
00850022775116
Brand
SPRINT
Company
SPR THERAPEUTICS, INC.
Model
80118
Catalog number
80118
Device description
SPRINT extensa MicroLead Connectors, Breakaway Connectors, and Key, Sterile
Published
2021-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain ReliefNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202660000SPRINT PNS SystemSpr Therapeutics, Inc.2021-01-22NHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022775116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022775116008500227751168500227751160850022775116

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic PENS systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius55 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963383778
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022775260SPRINT9619-40C9619-40C2026-05-19
00850022775079SPRINT9244-6001B9244-6001B2021-10-25
00850022775062SPRINT80101801012020-12-18
00854001007984SPRINT80096800962020-09-25
00854001007724SPRINT9618-63B9618-63B2020-03-06
00854001007823SPRINT80077800772020-03-06
00854001007830SPRINT80078800782020-03-06
00854001007847SPRINT80079800792020-03-06
00854001007854SPRINT80080800802020-03-06
00854001007861SPRINT80081800812020-03-06
00854001007878SPRINT80082800822020-03-06
00854001007908SPRINT80085800852020-03-06
00854001007403SPRINTMounting Pad, Sterile96192018-09-14
00854001007410SPRINTMounting Pad, Non-Sterile96182018-09-14
00854001007564SPRINTPatient Kit, Endura800352018-09-14
00854001007571SPRINTPatient Kit, Extensa800362018-09-14
00854001007236SPRINT™Pad I92372017-01-19
00854001007243SPRINT™Stimulator, Pads, and Accessories92382017-01-19
00854001007250SPRINT™MicroLead (20cm) and Accessories92392017-01-19
00854001007267SPRINT™Stimulator, Storage Bag, Patient Cables, and IFU92402017-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064328POSP DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-05-22
00850022775260SPRINTSPR THERAPEUTICS, INC.NHI2026-05-19
08908006064199Primary Relief NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064212NociRelief NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064236NS100NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
08908006064267ANSiSTIM - PP NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-03-16
00850022775000SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775017SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775222SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775239SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775246SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775253SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775376SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775383SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775444SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775451SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775468SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775475SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775482SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775499SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775505SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775512SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775529SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775536SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775543SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775550SPRINTSPR THERAPEUTICS, INC.NHI2026-01-06
00850022775413SPRINTSPR THERAPEUTICS, INC.NHI2025-08-21
08908006064250NEUMONANEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2025-08-18
08908006064168POSP Device NEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2025-05-19
00850022775390SPRINTSPR THERAPEUTICS, INC.NHI2024-08-30