FIBER INTUBATION SCOPE

Basic Information

• Brand Name: FIBER INTUBATION SCOPE
• Primary DI: 04961333240302
• Version / Model: FI-16RBS
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-12
• Public Version: 1
• Public Version Date: 2018-04-12
• Public Version Status: New
• Public Device Record Key: 7bb4e99a-d4af-4b3a-a8ac-23ca71aaab0b

Device Description

FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED)

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: 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: ["Ethylene Oxide", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAL	Laryngoscope, Non-Rigid	Anesthesiology	868.5530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36706	Flexible fibreoptic intubation laryngoscope	An endoscope with a flexible inserted portion intended for the visual examination of the upper airway and to assist the entry and positioning of a special airway tube [a long thin version of an endotracheal (ET) tube] to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is very long and thin to facilitate entry and the intubation procedure. Anatomical images are transmitted to the user by the device through 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	04961333240302	GS1