ACCLARENT PIVOT

Basic Information

• Brand Name: ACCLARENT PIVOT
• Primary DI: 20705031465616
• Version / Model: PVT0616Z
• Catalog Number: PVT0616Z
• Company Name: ACCLARENT, INC.
• Labeler DUNS: 361092450
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-01
• Public Version: 1
• Public Version Date: 2020-10-09
• Public Version Status: New
• Public Device Record Key: 12f6ae63-d9bf-4b35-aecf-3e52fa5aacef

Device Description

ACCLARENT PIVOT Balloon Dilation System - 1PK

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
PNZ	Eustachian tube balloon dilation device	Ear, Nose, Throat	874.4180	2
PGW	Ear, Nose, and Throat Stereotaxic Instrument	Neurology	882.4560	2
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10718	Eustachian catheter, single-use	A long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown through the device and into the middle ear. It is typically made of plastic. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20705031465616	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201115	000

Storage Conditions

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