Synergy MSK Ultrasound Strl Cover & Parker Gel

GUDID B748AR350050DEU0

Sterile ultrasound probe cover and ultrasound gel.

SAFERSONIC Medizinprodukte Handels GmbH

Coupling gel, sterile Topical coupling gel, sterile Topical coupling gel, sterile Topical coupling gel, sterile Topical coupling gel, sterile Topical coupling gel, sterile Topical 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.