InThrill Sheath 53-101

GUDID 00810123710294

InThrill Sheath (AS-01403)

INARI MEDICAL INC

Thrombectomy wire-net introduction set

• Primary Device ID: 00810123710294
• NIH Device Record Key: 59a0da53-b7c4-4490-9393-6283d89c8295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InThrill Sheath
• Version Model Number: 53-101
• Catalog Number: 53-101
• Company DUNS: 076827459
• Company Name: INARI 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: true
• Device Combination Product: false
• Single Use: false
• 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: 18779234747
• Email: info@inarimedical.com
• Phone: 18779234747
• Email: info@inarimedical.com
• Phone: 18779234747
• Email: info@inarimedical.com
• Phone: 18779234747
• Email: info@inarimedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810123710126 [Previous]
GS1	00810123710294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250421

FDA Product Code

• QEW: Peripheral Mechanical Thrombectomy With Aspiration

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: 2025-06-09
• Device Publish Date: 2025-05-30

On-Brand Devices [InThrill Sheath]

• 00850291007369: InThrill Sheath (InThrill Thrombectomy System)
• 00810123710294: InThrill Sheath (AS-01403)