RELIEVA SIDEKICK LP

Basic Information

• Brand Name: RELIEVA SIDEKICK LP
• Primary DI: 10705031063549
• Version / Model: SDKKLP
• Catalog Number: SDKKLP
• 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: 4
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 04418789-b3a4-4514-a423-57f8033d8270

Device Description

RELIEVA SIDEKICK SINUS GUIDE HANDLE LOW PROFILE

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: Yes
• 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
KAM	CANNULA, SINUS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48143	Paranasal sinus guide-catheter handle	A sterile, hand-held, tubular device designed to create an extension from which the user can stabilize the position of a sinus guide catheter. It typically has a malleable handle and a press-fit connector at the distal end for connection to the guide catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705031063546	GS1	BOX	5	In Commercial Distribution
Primary	10705031063549	GS1

Customer Contacts

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

Storage Conditions

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