N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333241972
• Version / Model: 68391-ACC
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-06
• Public Version: 1
• Public Version Date: 2018-04-06
• Public Version Status: New
• Public Device Record Key: 0248184f-d7fe-498c-bf20-031d69f03cbb

Device Description

COMPUTER ACCESSORIES

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: No
• PM Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36859	Computer terminal	An electronic or electromechanical hardware device designed to enter data into, and display data from, a computer or computing system (e.g., central mainframe computer, laboratory computing system), but is itself without data computing capabilities. It is intended as a human-machine interface, and typically consists of a keyboard, mouse, and a visual display unit (VDU) designed to be stationary on a desk or other work platform.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333241972	GS1