Ultrasonic transducer

GUDID 06944413809055

Edan Instruments, Inc.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 06944413809055
• NIH Device Record Key: ad2e4973-4303-4a3a-96bd-c5d27095ffbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasonic transducer
• Version Model Number: MC9-3TQ
• Company DUNS: 529173163
• Company Name: Edan Instruments, 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944413809055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180862

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: 2
• Public Version Date: 2018-10-16
• Device Publish Date: 2018-06-30

On-Brand Devices [Ultrasonic transducer]

• 06944413809062: MC9-3TD
• 06944413809055: MC9-3TQ
• 06944413809031: P7-3Q
• 06944413809024: P7-3D
• 06944413809000: P5-1Q
• 06944413808997: P5-1D
• 06944413808713: C321-2
• 06944413808232: C5-2MQ
• 06944413808218: L12-5Q
• 06944413808201: MC8-4Q
• 06944413808089: C5-2D
• 06944413807297: MC8-4D
• 06944413807280: L12-5D
• 06944413807273: C5-2Q
• 06944413806702: C5-2XQ
• 06944413806597: P5-1b
• 06944413806573: C5-2b
• 06944413806566: L15-7b
• 06944413806542: L761-2
• 06944413806535: L743-2
• 06944413806528: C341-2
• 06944413806504: C611-2
• 06944413806481: E611-2
• 06944413806467: C422UB
• 06944413806450: C612UB
• 06944413806443: C6152UB
• 06944413806429: L552UB
• 06944413806399: E612UB
• 06944413806382: L1042UB
• 06944413806375: L742UB
• 06944413806368: C352UB
• 06944413806245: C363-2
• 06944413806238: C363-1
• 06944413806153: E613
• 06944413806146: E741
• 06944413806122: L741
• 06944413806115: C341
• 06944413806108: C343-1
• 06944413806092: C361-1
• 06944413806085: E743
• 06944413806078: P5-1XD
• 06944413806061: L17-7SD
• 06944413806054: L17-7HD
• 06944413806047: L10-4D
• 06944413806030: E8-4D
• 06944413806023: C5-2XD
• 06944413806016: C5-2MD
• 06944413806009: E8-4Q
• 06944413805996: C5-2XQ
• 06944413805958: E741-2