Sonic Window Sterile Transducer Cover

GUDID 90814277020127

Sterile Transducer Cover - individual cover in envelope

ANALOGIC CORPORATION

Hand-held ultrasound imaging system, body-surface Hand-held ultrasound imaging system, body-surface

• Primary Device ID: 90814277020127
• NIH Device Record Key: e42cf25f-ff6c-4715-89fa-feed633e5c64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonic Window Sterile Transducer Cover
• Version Model Number: 21-05012-01
• Company DUNS: 019677418
• Company Name: ANALOGIC 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: true
• Manufacturing Date: true
• 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: 978-326-1300
• Email: info@bkultrasound.com
• Phone: 978-326-1300
• Email: info@bkultrasound.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	90814277020127 [Primary]
GS1	90814277020134 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	90814277020141 [Package]; Contains: 90814277020134; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140126

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-21
• Device Publish Date: 2016-09-17

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