Transducer Covers

GUDID 00616784124834

DYNAREX CORPORATION

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 00616784124834
• NIH Device Record Key: bf231cd1-ef48-42af-a29b-19a513116db4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer Covers
• Version Model Number: 1248
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784124803 [Unit of Use]
GS1	00616784124810 [Primary]
GS1	00616784124834 [Package]; Contains: 00616784124810; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022156

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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