FDA.reportPublic FDA data

Personal Medical Corp

Primary DI
08519520070032
Brand
Personal Medical Corp
Company
PERSONAL MEDICAL CORP.
Model
2 Channel MEP Adaptor
Catalog number
4695G
Device description
Electromyography Lead -- 2 Channel MEP Adaptor
Published
2016-12-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08519520070032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08519520070032085195200700328519520070032

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous leadAn insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG) and is not a dedicated neuromuscular transmission (NMT) lead set. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
425-242-6373info@personalmed.com

Regulatory Flags#

DUNS number
078511333
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08519520070009IVS-2Intravaginal Sensor45252016-10-18
08519520070010MEPAnal Sensor45202016-10-18
08519520070018EvaCare PessaryDish Pessary with SupportDSHS2016-12-06
08519520070025EvaCare PessaryCube Pessary with DrainCUD2016-12-06
08519520070063SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-12-06
08519520070070IVS-2Intravaginal Sensor45252016-12-06
08519520070087MEPAnal Sensor45202016-12-06
08519520070148EvaCare PessaryGellhorn PessaryGD2016-12-06
08519520070034Personal Medical Corp2 Channel MEP Adaptor4695G2016-10-31
08519520073347C3 Male Continence Device9103002018-08-27
08519520070001EvaCare PessaryRingR2016-10-10
08519520070007EvaCare PessaryRing w/ SupportRS2016-10-10
08519520070049EvaCare PessaryRing w/ SupportRS2016-12-06
08519520070003SenseRx -- Anal/Small Vaginal and Vaginal EMG4510C4510C2016-10-04