SPIWay SP004

GUDID 00860003136409

SPIWay Endonasal Access Guide Size Large

SPIWAY LLC

Intranasal splint, non-biodegradable

• Primary Device ID: 00860003136409
• NIH Device Record Key: ca4af77a-8ba2-4294-9590-24641d7cec4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIWay
• Version Model Number: SP004
• Catalog Number: SP004
• Company DUNS: 053144550
• Company Name: SPIWAY LLC
• Device Count: 5
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com
• Phone: 1-844-565-1226
• Email: orders@spiway.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003136409 [Primary]
GS1	10860003136406 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180141

FDA Product Code

• LYA: Splint, Intranasal Septal

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: 2020-08-12
• Device Publish Date: 2020-08-04

On-Brand Devices [SPIWay]

• 00860003136416: SPIWay Endonasal Access Guide Size Medium
• 00860003136409: SPIWay Endonasal Access Guide Size Large