MedaSonics

GUDID 00888937002522

Versatone P81 Probe; 2.4MHz; 3.3cm

Coopersurgical, Inc.

Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe Noninvasive vascular ultrasound system probe

• Primary Device ID: 00888937002522
• NIH Device Record Key: 9a8f2dad-b71b-4d03-93ca-905077775a5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedaSonics
• Version Model Number: 101-0012-010
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937002522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961116

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-18

On-Brand Devices [MedaSonics]

• 00888937002621: CardioBeat Vascular Doppler with Speaker; without Display; 5MHz
• 00888937002614: First Beat Fetal Doppler with Speaker; without Display
• 00888937002607: CardioBeat Doppler with Stethoscope; 5MHz
• 00888937002591: CardioBeat Doppler with Calc Display, Speaker, 5MHz
• 00888937002584: First Beat Doppler with Headphones
• 00888937002577: First Beat Fetal Doppler with Stethoscope
• 00888937002560: First Beat Fetal Doppler with Calc Display and Speaker
• 00888937002553: BF4B Vascular Doppler with Stethocope; 5 MHz
• 00888937002546: Versatone P83 Probe; 8MHz; 2.5cm
• 00888937002539: Versatone P82 Probe; 8MHz; 11.5cm
• 00888937002522: Versatone P81 Probe; 2.4MHz; 3.3cm
• 00888937002515: Versatone D8 Doppler 220V AC
• 00888937002508: Versatone D8 Doppler 115V AC