DEVICE: Ultramatrix (00724995180775)

Device Identifier (DI) Information

Ultramatrix
USBOR
In Commercial Distribution
USBOR
US Endoscopy
00724995180775
GS1

1
627879687 *Terms of Use
00816765014332
Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ODG Endoscopic ultrasound system, gastroenterology-urology
ITX Transducer, ultrasonic, diagnostic
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep Dry
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

a57ab119-3fef-4a9c-a7c6-3d4f73c75b47
November 10, 2020
2
April 02, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10724995180772 20 00724995180775 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)548-4873
xx@xx.xx
CLOSE