Ultramatrix EUS Linear Balloon for Pentax

Basic Information

• Brand Name: Ultramatrix EUS Linear Balloon for Pentax
• Primary DI: 00864390000343
• Version / Model: USB-PL
• Catalog Number: USB-PL
• Company Name: N. M. BEALE COMPANY, INC.
• Labeler DUNS: 780056289
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-07
• Public Version: 4
• Public Version Date: 2020-03-18
• Public Version Status: Update
• Public Device Record Key: 2d0f675c-9d2d-4d7d-b932-c19bba50a5d6
• Distribution End Date: 2017-12-31

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: 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
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
Primary	00864390000343	GS1

Customer Contacts

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