PENTAX

Basic Information

• Brand Name: PENTAX
• Primary DI: 04961333113545
• Version / Model: OF-A67
• Company Name: HOYA CORPORATION
• Labeler DUNS: 691519705
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2017-04-07
• Public Version: 5
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: bf24ed83-6780-4cc6-aa2a-5120051c2a2d

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODG	Endoscopic ultrasound system, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60608	Body-orifice ultrasound imaging transducer cover, basic	A sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333113545	GS1
Unit of Use	84961333113541	GS1

Premarket Submissions

Submission Number	Supplement Number
K130247	000