RELIEVA LUMA SENTRY SIS100BZ

GUDID 20705031135649

RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM, 1 PK

ACCLARENT, INC.

Paranasal sinus-illumination light guide cable Paranasal sinus-illumination light guide cable

• Primary Device ID: 20705031135649
• NIH Device Record Key: 12fffdc4-59ea-431c-8b87-0a1449d77d68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIEVA LUMA SENTRY
• Version Model Number: SIS100BZ
• Catalog Number: SIS100BZ
• Company DUNS: 361092450
• Company Name: ACCLARENT, 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: true
• 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: +1(650)687-5888
• Email: xx@xx.xx
• Phone: +1(650)687-5888
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705031135649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071845

FDA Product Code

• EQH: SOURCE, CARRIER, FIBEROPTIC LIGHT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-22
• Device Publish Date: 2016-10-01

On-Brand Devices [RELIEVA LUMA SENTRY]

• 20705031135649: RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM, 1 PK
• 20705031135632: RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM