ReTAP® Cardiovascular Patch FG0008-08

GUDID B042FG0008081

9mm ID x 6cm length x 210 degrees

SOLINAS MEDICAL INC.

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• Primary Device ID: B042FG0008081
• NIH Device Record Key: 8a5b0450-d2a3-49f4-8694-10d4af421235
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReTAP® Cardiovascular Patch
• Version Model Number: FG0008-08
• Catalog Number: FG0008-08
• Company DUNS: 962898792
• Company Name: SOLINAS MEDICAL 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com
• Phone: 650.427.9835
• Email: info@solinasmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B042FG0008081 [Primary]

FDA Product Code

• DXZ: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-01

On-Brand Devices [ReTAP® Cardiovascular Patch]

• B042FG0008251: 10mm ID x 5cm length x 210 degrees
• B042FG0008241: 9mm ID x 5cm length x 210 degrees
• B042FG0008231: 8mm ID x 5cm length x 210 degrees
• B042FG0008221: 7mm ID x 5cm length x 210 degrees
• B042FG0008211: 6mm ID x 5cm length x 210 degrees
• B042FG0008101: 10mm ID x 6cm length x 210 degrees
• B042FG0008081: 9mm ID x 6cm length x 210 degrees
• B042FG0008061: 8mm ID x 6cm length x 210 degrees
• B042FG0008041: 7mm ID x 6cm length x 210 degrees
• B042FG0008021: 6mm ID x 6cm length x 210 degrees