ULTRASIL

Basic Information

• Brand Name: ULTRASIL
• Primary DI: 00821925039728
• Version / Model: 70245756
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 8
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: 50e2b675-947a-47bb-932c-7f06d6bfba0f
• Distribution End Date: 2017-12-04

Device Description

PAPARELLA 2000 VENT TUBE 60 PACK 1.14 MM ID ULTRASIL SOFT SILICONE WITH TAB

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: No
• 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
ETD	Tube, Tympanostomy	Ear, Nose, Throat	874.3880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33794	Tympanostomy tube	A small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925039728	GS1
Unit of Use	00821925040830	GS1
Package	00821925026612	GS1		60	Not in Commercial Distribution	2017-12-04

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K932166	000