N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333241996
• Version / Model: 7174-8301-KIT
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-03-14
• Public Version: 1
• Public Version Date: 2018-04-16
• Public Version Status: New
• Public Device Record Key: 6886e2e1-056d-4e40-88b5-f7f159ec5abb

Device Description

ENDOSCOPIC HOLDER

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	868.6175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47081	Endoscope transport trolley tray	A support platform designed as a flat, shallow vessel with a raised rim, that functions as a component of an endoscope transport trolley [i.e., it inserts into the trolley (cart)]. It provides a protective space for the transport and short-term storage of a sterile or contaminated endoscope, endoscope accessories, or other sensitive equipment. It is typically made from plastic materials, is available in a variety of sizes, and may be fitted with a cover lid. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333241996	GS1
Unit of Use	14961333241993	GS1