RIGID SCOPES

Basic Information

• Brand Name: RIGID SCOPES
• Primary DI: 04961333240555
• Version / Model: 9109
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-27
• Public Version: 2
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 113aa9ea-bedb-4a8e-ab0d-45244947fc0b

Device Description

RIDID ENDOSCOPE,STERRAD NX CO

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Liquid Chemical", "Ethylene Oxide", "Moist Heat or Steam Sterilization", "High-level Disinfectant", "Sound Waves"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EQL	Laryngostroboscope	Ear, Nose, Throat	874.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35205	Rigid optical nasopharyngoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333240555	GS1

Device Sizes

Type	Value	Unit	Text
Angle	70.0	degree
Outer Diameter	8.5	Millimeter