SeptAlign SPLN001

GUDID 00860011696308

SPIRAIR, INC.

Nasal cartilage support implant, bioabsorbable

• Primary Device ID: 00860011696308
• NIH Device Record Key: 035747a0-2628-4205-abd1-fad4fe4aa059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeptAlign
• Version Model Number: FG-0032
• Catalog Number: SPLN001
• Company DUNS: 111289449
• Company Name: SPIRAIR, 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	00860011696308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233569

FDA Product Code

• NHB: Polymer, Ear, Nose And Throat, Synthetic, Absorbable

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: 2024-10-24
• Device Publish Date: 2024-10-16

On-Brand Devices [SeptAlign]

• 00860011696315: FG-0032
• 00860011696308: FG-0032