Gendex GXC-300™ intraoral camera sheaths 109 0507P1

GUDID EKAV082225320

500 Count

GENDEX CORP.

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: EKAV082225320
• NIH Device Record Key: c9806a94-f0cb-4eea-84e6-cf085ff8e975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gendex GXC-300™ intraoral camera sheaths
• Version Model Number: 0.822.2532
• Catalog Number: 109 0507P1
• Company DUNS: 144575763
• Company Name: GENDEX CORP.
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18003238029
• Email: info@gendex.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	0EKAV082225320 [Unit of Use]
HIBCC	EKAV082225320 [Primary]

FDA Product Code

• KQM: CAMERA, SURGICAL AND ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Gendex GXC-300™ intraoral camera sheaths]

• EKAV082226450: 100 Count
• EKAV082225320: 500 Count