FDA.reportPublic FDA data

Mainstay Tunneler

Primary DI
05391527772415
Brand
Mainstay Tunneler
Company
MAINSTAY MEDICAL LIMITED
Model
7MTUN1-002
Catalog number
TUN1
Device description
Tunneler, US configuration
Published
2021-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain ReliefUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P190021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P190021000ReActiv8 Implantable Neurostimulation SystemMainstay Medical Limited2020-06-16QLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391527772415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391527772415053915277724155391527772415

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-702-8488info@mainstay-medical.com

Regulatory Flags#

DUNS number
985519015
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391527771357ReActiv8 Programmer 6M7500-0112025-05-22
05391527771364ReActiv8 Programmer 6M7500-0122025-05-22
05391527770626ReActiv8 Magnet6M4000-00340002021-01-25
05391527772071ReActiv8 Stimulation Lead7M8145-00681452021-01-25
05391527772279ReActiv8 Stimulation Lead7M8165-00681652021-01-25
05391527770046ReActiv8 IPG7M5100-00551002025-02-13
05391527772804ReActiv8 Release ToolEXT12024-01-22
05391527770633ReActiv8 Magnet6M4000-00440002021-01-25
05391527770213ReActiv8 Programming Wand6M6000-00260002021-01-25
05391527770411ReActiv8 Activator6M7000-00270002021-01-25
05391527772064ReActiv8 Stimulation Lead7M8145-00581452021-01-25
05391527772262ReActiv8 Stimulation Lead7M8165-00581652021-01-25
05391527770015ReActiv8 IPG7M5100-00251002021-01-25
05391527770817ReActiv8 Torque Wrench7M5500-00255002021-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391527771357ReActiv8 Programmer MAINSTAY MEDICAL LIMITEDQLK2025-05-22
05391527771364ReActiv8 Programmer MAINSTAY MEDICAL LIMITEDQLK2025-05-22
05391527770046ReActiv8 IPGMAINSTAY MEDICAL LIMITEDQLK2025-02-13
05391527770015ReActiv8 IPGMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770213ReActiv8 Programming WandMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770411ReActiv8 ActivatorMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770626ReActiv8 MagnetMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770633ReActiv8 MagnetMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527770817ReActiv8 Torque WrenchMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772064ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772071ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772262ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25
05391527772279ReActiv8 Stimulation LeadMAINSTAY MEDICAL LIMITEDQLK2021-01-25