N/A D128207

GUDID 10841898127748

PentaRay Nav Eco High-Density Mapping Catheter, 7F

INNOVATIVE HEALTH LLC

Cardiac mapping catheter, percutaneous, reprocessed

• Primary Device ID: 10841898127748
• NIH Device Record Key: b2ee82a6-c4db-49b6-9a81-dcb1926e3efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: D128207
• Company DUNS: 015575953
• Company Name: INNOVATIVE HEALTH LLC
• 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: false
• Serial Number: true
• 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: 877-400-3740
• Email: regulatory@innovative-health.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841898127748 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190785

FDA Product Code

• NLG: Catheter, Intracardiac Mapping, High-Density, Reprocessed

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-22
• Device Publish Date: 2019-07-12

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