FDA.reportPublic FDA data

SPRINT

Primary DI
00850022775260
Brand
SPRINT
Company
SPR THERAPEUTICS, INC.
Model
9619-40C
Catalog number
9619-40C
Device description
Mounting Pad - Sterile
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
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
K223306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223306000SPRINT Peripheral Nerve Stimulation (PNS) SystemSpr Therapeutics, Inc.2023-01-25NHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022775260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022775260008500227752608500227752600850022775260

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

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
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
00854001007274SPRINT™Pad II92412017-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908006064328POSP DeviceNEUROSTIMULATION MEDTECH PRIVATE LIMITEDNHI2026-05-22
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
00850022775406SPRINTSPR THERAPEUTICS, INC.NHI2024-08-30