PENTAX

Basic Information

• Brand Name: PENTAX
• Primary DI: 04961333075348
• Version / Model: OS-H4
• Company Name: HOYA CORPORATION
• Labeler DUNS: 691519705
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 2
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6a8e8b09-2cdb-465b-8a64-957e60bb9b1a

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: 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: ["Moist Heat or Steam Sterilization", "Sound Waves"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PEA	Endoscope, accessories, image post-processing for color enhancement	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42841	Intravenous/irrigation solution storage container, reusable	An empty glass or plastic receptacle, capable of being sterilized, intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333075348	GS1