Ultracell®

Basic Information

• Brand Name: Ultracell®
• Primary DI: 30886158014783
• Version / Model: SM-NS30305-C
• Catalog Number: SM-NS30305-C
• Company Name: Beaver-Visitec International, Inc.
• Labeler DUNS: 001406024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-06
• Public Version: 1
• Public Version Date: 2024-06-14
• Public Version Status: New
• Public Device Record Key: 7ce7c128-2c6b-4cca-af2a-66ae9b28b492

Device Description

***NON-STERILE*** SHIPPERT MED FENESTRATED EAR WICK, 9MM DIA X 15MM (250/SP)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCN	EAR WICK	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33468	Ear wick, non-biodegradable	A non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30886158014783	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K920357	000

Storage Conditions

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