Ultramatrix

Basic Information

• Brand Name: Ultramatrix
• Primary DI: 00724995180775
• Version / Model: USBOR
• Catalog Number: USBOR
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-02
• Public Version: 2
• Public Version Date: 2020-11-10
• Public Version Status: Update
• Public Device Record Key: a57ab119-3fef-4a9c-a7c6-3d4f73c75b47

Device Description

Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.

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: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODG	Endoscopic ultrasound system, gastroenterology-urology	Gastroenterology, Urology	876.1500	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62177	Ultrasound endoscope balloon, synthetic polymer	A sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995180772	GS1	Case	20	In Commercial Distribution
Primary	00724995180775	GS1
Previous	00816765014332	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry