FDA.report

PMT CORPORATION

Primary DI
00650551003076
Brand
PMT CORPORATION
Company
PMT CORPORATION
Model
2127-16-04-Y8
Device description
64 CONTACT INTERCONNECTION CABLE, Y-SPLIT INLINE CONNECTOR
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
IKDCable, Electrode

Product Code Classifications

CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00650551003076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551003076006505510030766505510030760650551003076

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

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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00650551002086PMT® SUCTION INSTRUMENTS9001-06-2252025-03-19
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00650551002833INTEGRA®3612-06R-IR-ST2025-03-19
00650551002932ALLURA®3321-214-T2025-03-19
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00650551003083INTEGRA®3610-23-32025-03-19
00650551003090INTEGRA®3611-674-32025-03-19
00650551003168INTEGRA®3611ES-12-IR-ST2025-03-19
00650551003175INTEGRA®3611ES-13-IR-ST2025-03-19
00650551003182INTEGRA®3612ES-04R-IR-ST2025-03-19
00650551003205INTEGRA®3610-579-22025-03-19
00650551003212INTEGRA®3611-675-22025-03-19

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