PENTAX

Basic Information

• Brand Name: PENTAX
• Primary DI: 04961333127184
• Version / Model: OE-B3
• Company Name: HOYA CORPORATION
• Labeler DUNS: 691519705
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-31
• Public Version: 1
• Public Version Date: 2023-08-08
• Public Version Status: New
• Public Device Record Key: 3968f9dd-d07e-4748-baec-422786ce0389

Device Description

ElevatorWireCleaningInletCap For UltrasoundEndoscopes OE-B3

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: ["High-level Disinfectant", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65839	Endoscope fluid protection cap	A small, closed-ended attachment intended to be attached to an endoscope channel/port (e.g., light source socket) to prevent exposure of the endoscope interior to fluids during sterilization/cleaning; it is not intended to be used during a medical procedure and does not incorporate a filter or valve. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333127184	GS1

Premarket Submissions

Submission Number	Supplement Number
K162447	000