RELIEVA LUMA SENTRY

Basic Information

• Brand Name: RELIEVA LUMA SENTRY
• Primary DI: 20705031135649
• Version / Model: SIS100BZ
• Catalog Number: SIS100BZ
• Company Name: ACCLARENT, INC.
• Labeler DUNS: 361092450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-01
• Public Version: 5
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 12fffdc4-59ea-431c-8b87-0a1449d77d68

Device Description

RELIEVA LUMA SENTRY SINUS ILLUMINATION SYSTEM, 1 PK

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
EQH	SOURCE, CARRIER, FIBEROPTIC LIGHT	Ear, Nose, Throat	874.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48144	Paranasal sinus-illumination light guide cable	A sterile device designed to transmit cold light via a guidewire into the sinus cavities to provide illumination of the operative site during diagnostic and therapeutic procedures in conjunction with other nasal and sinus devices. It is typically a flexible light cable with a fibreoptic core which tapers at the distal end into a long, thin, probe that is capable of being manoeuvred into the various cavities; the proximal end will attach to an appropriate light source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20705031135649	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071845	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place