Gendex GXC-300™ intraoral camera sheaths

Basic Information

• Brand Name: Gendex GXC-300™ intraoral camera sheaths
• Primary DI: EKAV082225320
• Version / Model: 0.822.2532
• Catalog Number: 109 0507P1
• Company Name: GENDEX CORP.
• Labeler DUNS: 144575763
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c9806a94-f0cb-4eea-84e6-cf085ff8e975

Device Description

500 Count

Device Characteristics

• Single Use: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KQM	CAMERA, SURGICAL AND ACCESSORIES	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43970	Cable/lead/sensor/probe cover, sterile	A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV082225320	HIBCC
Unit of Use	0EKAV082225320	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius