Nimbus Electrosurgical Radiofrequency Multitined E

GUDID B452NIM10010BB1

BIOMERICS, LLC

Radio-frequency ablation system probe cannula, single-use

• Primary Device ID: B452NIM10010BB1
• NIH Device Record Key: a689eef3-aadb-491b-979f-c18ab51d4b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nimbus Electrosurgical Radiofrequency Multitined E
• Version Model Number: NIM10010BB
• Company DUNS: 829708036
• Company Name: BIOMERICS, LLC
• Device Count: 10
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com
• Phone: 8013552705
• Email: csr@biomerics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B452NIM10010BB1 [Primary]
HIBCC	D20180928Q10 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121773

FDA Product Code

• GXI: Probe, Radiofrequency Lesion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-03

On-Brand Devices [Nimbus Electrosurgical Radiofrequency Multitined E]

• B452NIM15010BB1: NIM15010BB
• B452NIM15010BB0: NIM15010BB
• B452NIM10010BBCS1: NIM10010BBCS
• B452NIM10010BBCS0: NIM10010BBCS
• B452NIM10010BB1: NIM10010BB
• B452NIM10010BB0: NIM10010BB
• B452NIM05010BB1: NIM05010BB
• B452NIM05010BB0: NIM05010BB