PMT® CORPORATION - SPHENOIDAL 2101-32-01

GUDID 10650551092749

STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED

PMT CORPORATION

Depth electrode

• Primary Device ID: 10650551092749
• NIH Device Record Key: ea1f35cc-57f7-41b5-b43c-da7cf228a1db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMT® CORPORATION - SPHENOIDAL
• Version Model Number: 2101-32-01
• Catalog Number: 2101-32-01
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-626-5463
• Email: intl@pmtcorp.com
• Phone: 800-626-5463
• Email: intl@pmtcorp.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit
• Storage Environment Temperature: Between 58 Degrees Fahrenheit and 78 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551092742 [Primary]
GS1	10650551092749 [Package]; Contains: 00650551092742; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033730

FDA Product Code

• GZL: Electrode, Depth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-23
• Device Publish Date: 2016-11-17

On-Brand Devices [PMT® CORPORATION - SPHENOIDAL]

• 00650551092988: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
• 00650551092971: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
• 10650551092947: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
• 10650551092923: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
• 10650551092909: STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
• 10650551092886: STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
• 00650551092797: CRIMPING TOOL FOR NON-CRIMPED SPHENOIDAL ELECTRODE
• 00650551092780: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
• 00650551092773: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
• 10650551092763: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
• 10650551092756: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
• 10650551092749: STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
• 10650551092732: STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
• 10650551092992: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
• 10650551092961: PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
• 10650551092954: PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
• 10650551092930: PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
• 10650551092916: STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
• 10650551092893: STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
• 10650551092879: SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
• 10650551092862: SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
• 10650551092855: PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
• 10650551092848: PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
• 10650551092831: PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
• 10650551092824: PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
• 10650551092817: STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
• 10650551092800: STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED