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Ultramatrix

FDA UDI

Class II (US FDA UDI)

by US Endoscopy

Identity

Trade Name
Ultramatrix FDA UDI
Generic Name
Ultrasound endoscope balloon, synthetic polymer FDA UDI
Device Name
The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract. FDA UDI
Model / Reference
USBOL FDA UDI
Description
The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract. FDA UDI

Identifiers

Catalog Number
USBOL FDA UDI
Primary DI / UDI-DI
00724995180768 FDA UDI
FDA Product Code
ODG FDA UDI
ITX FDA UDI
GMDN Term
Ultrasound endoscope balloon, synthetic polymer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Ultrasound endoscope balloon, synthetic polymer

Ultramatrix by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound endoscope balloon, synthetic polymer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
US Endoscopy

Sources (1)

  • FDA UDI d23cdebb-231d-4581-8990-4c5d23a58f0d 36 fields · synced May 30, 2026