Pencil probe P8M05S8A

GUDID 00894912002418

Reusable CW Doppler pencil probe, 8 MHz

KOVEN TECHNOLOGY, INC.

Invasive vascular ultrasound system probe

• Primary Device ID: 00894912002418
• NIH Device Record Key: 438142ed-293b-4b2e-a7f2-e2f140c1a27c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pencil probe
• Version Model Number: P8M05S8A
• Catalog Number: P8M05S8A
• Company DUNS: 069261402
• Company Name: KOVEN TECHNOLOGY, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com
• Phone: 314-542-2101
• Email: info@koven.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00894912002418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934638

FDA Product Code

• JOP: Transducer, Ultrasonic

Sterilization

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

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

[00894912002418]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-06-29

On-Brand Devices [Pencil probe]

• 00894912002883: Reusable CW Doppler pencil probe, 8 MHz
• 00894912002890: Reusable CW Doppler pencil probe, 10 MHz
• 00894912002876: Reusable CW Doppler pencil probe, 5 MHz
• 00894912002715: Reusable CW Doppler pencil probe for HD307, 8 MHz
• 00894912002708: Reusable CW Doppler pencil probe for HD307, 10 MHz
• 00894912002418: Reusable CW Doppler pencil probe, 8 MHz
• 00894912002401: Reusable CW Doppler pencil probe, 5 MHz
• 00894912002395: Reusable CW Doppler pencil probe, 10 MHz