SENDERO

GUDID 00850008222078

Microcatheter

OKAMI MEDICAL, INC.

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

• Primary Device ID: 00850008222078
• NIH Device Record Key: 9df3a2ad-64ec-46ab-aea4-9fd91f30994f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SENDERO
• Version Model Number: SENDERO-MC29-130
• Company DUNS: 117045423
• Company Name: OKAMI 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850008222078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240384

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2024-04-15
• Device Publish Date: 2024-04-05

Devices Manufactured by OKAMI MEDICAL, INC.

• 00850008222078 - SENDERO: 2024-04-15Microcatheter
• 00850008222078 - SENDERO: 2024-04-15 Microcatheter
• 00850008222030 - LOBO: 2022-07-06 Peripheral Vascular Occluder
• 00850008222061 - LOBO: 2022-07-06 Peripheral Vascular Occluder
• 00850008222054 - LOBO: 2021-02-17 Peripheral Vascular Occluder
• 00850008222009 - LOBO: 2020-01-15 LOBO Handpiece
• 00850008222016 - LOBO: 2020-01-15 Peripheral Vascular Occluder