FDA.report

N/A

Primary DI
00650551141990
Brand
N/A
Company
PMT CORPORATION
Model
2120-06-01B-Y1-NS
Catalog number
2120-06-01B-Y1-NS
Device description
sEEG INTERCONNECTION CABLE, 6 CONTACT (6X1), MINI CONNECTOR, Y-SPLIT
Published
2018-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650551141990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551141990006505511419906505511419900650551141990

GMDN Terms

TermDefinition
Analytical scalp leadA wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.

Sterilization Methods

Method
Hydrogen Peroxide

Contacts

PhoneEmail
800-626-5463info@pmtcorp.com

Regulatory Flags

DUNS number
039576871
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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