N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333240685
• Version / Model: 9400
• 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: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 9c644af6-d291-4715-9a52-ab9dc5f0e6a3

Device Description

LARYNGEAL STROBE

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: 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: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
41585	Laryngostroboscope system	A device used to observe and record the intralaryngeal phenomenon of phonation (speech). It is comprised of a number of components, e.g., a rhino-laryngeal stroboscope unit, camera, video recorder, computer and software, and will typically be used together with an appropriate endoscope. It is typically used in ear/nose/throat (ENT) departments to investigate the correct functioning of the vocal apparatus (glottis) and to investigate voice disorders.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333240685	GS1

Premarket Submissions

Submission Number	Supplement Number
K921184	000