Paired VNS

Primary DI
10810041430080
Brand
Paired VNS
Company
Microtransponder
Model
3000
Device description
Lead, 3 mm cuff
Published
2022-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPYStimulator, Autonomic Nerve, Implanted For Stroke RehabilitationUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210007000Vivistim® SystemMobia Medical, Inc.2021-08-27QPY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810041430080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081004143008010810041430080

GMDN Terms#

Term, Definition table
TermDefinition
Vagus nerve electrical stimulation system leadAn implantable wire, insulated with non-conductive material except at its electrode(s), intended to be used to make an electrical connection between a pulse generator and the vagus nerve for vagus nerve stimulation (VNS).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
793502068
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810041430158MicroTransponder60012024-08-06
10810041430028Vivistim® 10012022-04-29
10810041430066Paired VNS30002022-04-29
10810041430004Vivistim40012022-03-28
10810041430042Paired VNS20002022-03-28
10810041430141Paired VNS21002022-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810041430028Vivistim® MicrotransponderQPY2022-04-29
10810041430066Paired VNSMicrotransponderQPY2022-04-29
10810041430004VivistimMicrotransponderQPY2022-03-28
10810041430042Paired VNSMicrotransponderQPY2022-03-28
10810041430141Paired VNSMicrotransponderQPY2022-03-28