FDA.reportPublic FDA data

SPRINT

Primary DI
00854001007564
Brand
SPRINT
Company
SPR THERAPEUTICS, INC.
Model
Patient Kit, Endura
Catalog number
80035
Device description
Patient Kit, SPRINT Endura
Published
2018-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NIHDisinfectant, Subsystem, Water Purification

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIHDisinfectant, Subsystem, Water PurificationGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854001007564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854001007564008540010075648540010075640854001007564

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic percutaneous electrical nerve stimulation 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
Kit
true
Lot or batch
true
Expiration date on label
true
Contains 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
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
00724995223298Minncare HDMEDIVATORS INC.NIH2024-03-26
50724995223293Minncare HDMEDIVATORS INC.NIH2024-03-26
00817724022894LuxisseHEANY INDUSTRIES, INC.NIH2019-11-05
00677964066863Minncare HDMEDIVATORS INC.NIH2018-01-09
00677964066870Minncare HDMEDIVATORS INC.NIH2018-01-09
00677964079498Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964066888Minncare HD Residual Test StripsMEDIVATORS INC.NIH2018-01-09
30677964066895Minncare HD 1% Indicator Test StripsMEDIVATORS INC.NIH2018-01-09
30677964066864Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964066871Minncare HDMEDIVATORS INC.NIH2018-01-09
30677964079499Minncare HDMEDIVATORS INC.NIH2018-01-09