Endocavity Probe EC9-3

GUDID 04560141944909

KONICA MINOLTA, INC.

Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 04560141944909
• NIH Device Record Key: 5da68888-12a0-4a6c-b831-d7a31b3f1587
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endocavity Probe EC9-3
• Version Model Number: A96C
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560141944909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162065

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: 2016-11-09

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