FDA.reportPublic FDA data

StimRouter Implantable Kit

Primary DI
00815962020016
Brand
StimRouter Implantable Kit
Company
BIONESS INC.
Model
ST2-1000
Device description
StimRouter Implantable Lead
Published
2016-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZFSTIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142432000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142432000StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User KitBioness, Inc.2015-02-20GZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815962020016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815962020016008159620200168159620200160815962020016

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic PENS system probe, single-useA sterile, hand-held electrical conductor intended to be used as part of an analgesic percutaneous electrical nerve stimulation (PENS) system to deliver controlled electrical impulses directly to subcutaneous tissue for the relief of chronic neuropathic pain. It is intended to be connected to an analgesic PENS system generator and its conductive length introduced percutaneously (invasively) into the patient, in the vicinity of a peripheral nerve. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)211-9136info@bioness.com

Regulatory Flags#

DUNS number
182287727
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815962021464StimRouter User KitST2-50502022-10-17
00815962020528H200 Wireless SystemH2W-53002019-08-08
00815962020535H200 Wireless SystemH2W-52002019-08-08
00815962020542H200 Wireless SystemH2W-55002019-08-08
00815962020559H200 Wireless SystemH2W-54002019-08-08
00815962020566H200 Wireless SystemH2W-40002019-08-08
00815962020573H200 Wireless SystemH2W-41002019-08-08
00815962020580H200 Wireless SystemH2W-51002019-08-08
00815962020597H200 Wireless SystemH2W-50002019-08-08
00815962020603H200 Wireless SystemH2W-47002019-08-08
07290110482008NESS H200® Wireless Hand Rehabilitation SystemH2W-5300501-00037-012017-02-02
07290110482015NESS H200® Wireless Hand Rehabilitation SystemH2W-5200501-00038-012017-02-02
07290110482022NESS H200® Wireless Hand Rehabilitation SystemH2W-5500501-00041-012017-02-02
07290110482039NESS H200® Wireless Hand Rehabilitation SystemH2W-5400501-00042-012017-02-02
07290110482046NESS H200® Wireless Hand Rehabilitation SystemH2W-4000501-00094-012017-02-02
07290110482053NESS H200® Wireless Hand Rehabilitation SystemH2W-4100501-00095-012017-02-02
07290110482060NESS H200® Wireless Hand Rehabilitation SystemH2W-5100501-00120-012017-02-02
07290110482077NESS H200® Wireless Hand Rehabilitation SystemH2W-5000501-00121-012017-02-02
07290110482084NESS H200® Wireless Hand Rehabilitation SystemH2W-4700501-00176-012017-02-02
00815962020290H200 WirelessH2W-SW012018-02-08

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