Gendex GXS-700™ intraoral sensor sheaths

Basic Information

• Brand Name: Gendex GXS-700™ intraoral sensor sheaths
• Primary DI: EKAV100810860
• Version / Model: 1.008.1086
• Catalog Number: 112 1433G1
• Company Name: GENDEX CORP.
• Labeler DUNS: 144575763
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: ee511a06-3dbe-4135-878c-9b304d8cea7e

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MMP	Cover, barrier, protective	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61049	Instrument/equipment drape, single-use, non-sterile	A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EKAV100810860	HIBCC
Unit of Use	0EKAV100810860	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius