Synergy MSK Ultrasound Strl Cover & Parker Gel

GUDID B748AR350050DEU0

Sterile ultrasound probe cover and ultrasound gel.

SAFERSONIC Medizinprodukte Handels GmbH

Coupling gel, sterile

• Primary Device ID: B748AR350050DEU0
• NIH Device Record Key: a16507e0-48eb-4c9e-8786-60ad940592bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy MSK Ultrasound Strl Cover & Parker Gel
• Version Model Number: AR-3500-50D-US
• Company DUNS: 300034922
• Company Name: SAFERSONIC Medizinprodukte Handels GmbH
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B748AR350050DEU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092858

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

On-Brand Devices [Synergy MSK Ultrasound Strl Cover & Parker Gel]

• B748AR350050DUS0: Sterile ultrasound probe cover and ultrasound gel.
• B748AR350050DEU0: Sterile ultrasound probe cover and ultrasound gel.