Transducer S8-3

GUDID 00884838067929

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00884838067929
• NIH Device Record Key: 3d13125d-1dfb-4c2f-886a-03f5a7a75f1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer S8-3
• Version Model Number: 989605361963
• Company DUNS: 063377717
• Company Name: Philips Ultrasound, 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	00884838067929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062247

FDA Product Code

• IYO: System, imaging, pulsed echo, ultrasonic

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: 2018-11-12
• Device Publish Date: 2016-03-31

On-Brand Devices [Transducer S8-3]

• 00884838067929: 989605361963
• 00884838067806: 989605361882
• 00884838067622: 989605440752