Ultracell®

Basic Information

• Brand Name: Ultracell®
• Primary DI: 30886158014288
• Version / Model: SS20200-C
• Catalog Number: SS20200-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: 2024-06-27
• Public Version: 1
• Public Version Date: 2024-07-05
• Public Version Status: New
• Public Device Record Key: 649eb0e4-3bd3-43c4-905b-718c327540c8

Device Description

SINUS PACK W/STRING (1,000/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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMX	BALLOON, EPISTAXIS	Ear, Nose, Throat	874.4100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46941	ENT space-occupying dressing, human-derived	A sterile, bioabsorbable material intended to be used to help heal tissue, limit adhesions between mucosal surfaces, and control bleeding after ear/nose/throat (ENT) surgery. It is typically available as gel or gelatin sponge of human tissue origin. In nasal/sinus applications it may be aspirated (removed) from the cavity before absorption.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30886158014288	GS1

Customer Contacts

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

Storage Conditions

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