SPIWay

Basic Information

• Brand Name: SPIWay
• Primary DI: 00860003136416
• Version / Model: SP005
• Catalog Number: SP005
• Company Name: SPIWAY LLC
• Labeler DUNS: 053144550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-08-04
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 41c221d1-bc03-4dea-8c77-6df2937af0d3

Device Description

SPIWay Endonasal Access Guide Size Medium

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	874.4780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31919	Intranasal splint, non-biodegradable	A non-biodegradable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is typically made of plastic, silicone, and/or a blood/liquid absorptive material and is removed at the discretion of the physician. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003136416	GS1
Unit of Use	10860003136413	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180141	000