GUDID 00840682118163

GE Healthcare Austria GmbH & Co OG

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00840682118163
• NIH Device Record Key: cd507272-bea0-4c99-9ad8-0c62e27ba8b8
• Commercial Distribution Discontinuation: 2019-12-09
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: RAB2-5
• Company DUNS: 300599979
• Company Name: GE Healthcare Austria GmbH & Co OG
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)437-1171
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682118163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041688

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: 5
• Public Version Date: 2020-05-11
• Device Publish Date: 2016-07-15

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