N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333243426
• Version / Model: KUMOF-Z5K
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2018-03-14
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 348ced45-968e-4540-91b9-4e9c67b973c9

Device Description

BITE BLOCK 3PCS ST

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: ["Ethylene Oxide", "Sound Waves"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	874.4760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10405	Seizure bite block	A non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333243426	GS1
Unit of Use	14961333243423	GS1

Premarket Submissions

Submission Number	Supplement Number
K172156	000