ECLIPSE 38-03

GUDID 10855683006354

Eclipse Probe Cover, 83mm/43x241mm

PARKER LABORATORIES INC

Body-surface ultrasound imaging transducer cover

• Primary Device ID: 10855683006354
• NIH Device Record Key: 3e2e3f0e-d53b-4449-ad1b-7ec39fc3ae73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECLIPSE
• Version Model Number: PROBE COVER-LATEX FREE
• Catalog Number: 38-03
• Company DUNS: 002449593
• Company Name: PARKER LABORATORIES INC
• Device Count: 100
• 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: true
• 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: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com
• Phone: 1-973-276-9500
• Email: Customersupport@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006357 [Unit of Use]
GS1	10855683006354 [Primary]
GS1	20855683006351 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953673

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: 5
• Public Version Date: 2024-06-05
• Device Publish Date: 2016-12-19

On-Brand Devices [ECLIPSE]

• 10855683006354: Eclipse Probe Cover, 83mm/43x241mm
• 10855683006347: Eclipse Probe Cover-latex free, 64 mm / 44 x 241 mm