DEVICE: PENTAX (04961333113545)

Device Identifier (DI) Information

PENTAX
OF-A67
Not in Commercial Distribution

HOYA CORPORATION
04961333113545
GS1
May 17, 2023
20
691519705 *Terms of Use
Balloon for PENTAX Ultrasound Endoscopes
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
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
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130247 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

bf24ed83-6780-4cc6-aa2a-5120051c2a2d
April 04, 2025
6
April 07, 2017
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
No Package DIs found
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: 84961333113541 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE