Eclipse Probe Cover

GUDID 00855683006869

A soft disposable ultrasound probe cover

PARKER LABORATORIES INC

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• Primary Device ID: 00855683006869
• NIH Device Record Key: b7d0efaf-b77f-48ed-a4f5-95ca52946222
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eclipse Probe Cover
• Version Model Number: 38-01-1
• 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: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com
• Phone: 973-276-9500
• Email: customerservice@parkerlabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855683006869 [Unit of Use]
GS1	10855683006866 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-10
• Device Publish Date: 2021-12-31

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• 00855683006890 - Alpha-Stim: 2022-03-09 Conducting Solution - 250 ml
• 00855683006869 - Eclipse Probe Cover: 2022-01-10A soft disposable ultrasound probe cover
• 00855683006869 - Eclipse Probe Cover: 2022-01-10 A soft disposable ultrasound probe cover
• 00855683006876 - Soterixmedical HD-Gel: 2021-11-30 High Definition Electrolyte Gel
• 10855683006859 - BioWrap: 2021-10-19 BioWrap Conductive Cream