PENTAX Medical

Basic Information

• Brand Name: PENTAX Medical
• Primary DI: 04961333233557
• Version / Model: OS-A111
• 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: c840e3c9-0627-4cf8-91c1-0fcf93c52cff

Device Description

PENTAX Medical Keyboard EN OS-A111

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: Yes
• 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
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2
PEA	Endoscope, Accessories, Image Post-Processing For Color Enhancement	Gastroenterology, Urology	876.1500	2
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62940	Computer/medical device keyboard	A desktop, electronic component of a computer/medical device intended to operate and/or control the use of the parent device. It has a panel of keys, including alpha-numeric characters, and may have touchscreen capability and/or specialized keys to control specialized functionality of the parent device. It is not dedicated to those with a disability.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333233557	GS1

Premarket Submissions

Submission Number	Supplement Number
K190805	000