N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333242191
• Version / Model: 9200D
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-08
• Public Version: 1
• Public Version Date: 2018-04-09
• Public Version Status: New
• Public Device Record Key: aa69f1be-517d-4b14-9f89-d5497ed73d3b

Device Description

DIGITAL VIDEO CAPTURE MODULE

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
13274	Video cassette recorder	A mains electricity (AC-powered), electronic, device designed to receive and store both image and sound on a magnetic video tape (a standard video cassette) as electronic signals. During recording, the inputs of the recorder's electronic circuitry and recording heads are connected to a video signal source (e.g., video or television camera). The information is retrieved through playback heads (that typically are an integral part of the recorder), and the output is connected to an appropriate monitor or is fed into another device for further manipulation. This is a general-purpose recording/playback device and is commonly called a VCR (video cassette recorder).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333242191	GS1