STERILE AQUASONIC 01-01

GUDID 00855683006005

Sterile Aquasonic 100 Ultrasound transmission gel 20 g over wrapped foil pouch

PARKER LABORATORIES INC

Electrode conductive medium

• Primary Device ID: 00855683006005
• NIH Device Record Key: 26d82c8b-699d-42a1-b1f5-a12cedfbc7f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILE AQUASONIC
• Version Model Number: ULTRASOUND TRANSMISSION GEL
• Catalog Number: 01-01
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-973-276-9500
• Email: Nbuchalter@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006005 [Primary]
GS1	10855683006002 [Package]; Package: BOX [48 Units]; In Commercial Distribution
GS1	20855683006009 [Package]; Contains: 10855683006002; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802146

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-12-19

On-Brand Devices [STERILE AQUASONIC]

• 00855683006005: Sterile Aquasonic 100 Ultrasound transmission gel 20 g over wrapped foil pouch
• 20855683006023: Sterile Aquasonic 100 Ultrasound Transmission gel, 20g packette