LOBO

GUDID 00850008222054

Peripheral Vascular Occluder

OKAMI MEDICAL, INC.

Non-neurovascular embolization plug, metallic

• Primary Device ID: 00850008222054
• NIH Device Record Key: df94c279-53e5-4ff1-8fa3-3f3c773d74f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOBO
• Version Model Number: LOBO-5
• Company DUNS: 117045423
• Company Name: OKAMI MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com
• Phone: 9494469710
• Email: info@okamimedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008222054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203025

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2021-02-17
• Device Publish Date: 2021-02-09

On-Brand Devices [LOBO]

• 00850008222016: Peripheral Vascular Occluder
• 00850008222009: LOBO Handpiece
• 00850008222054: Peripheral Vascular Occluder
• 00850008222061: Peripheral Vascular Occluder
• 00850008222030: Peripheral Vascular Occluder