Gendex GXS-700™ intraoral sensor sheaths 112 1433G1

GUDID EKAV100810860

GENDEX CORP.

Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: EKAV100810860
• NIH Device Record Key: ee511a06-3dbe-4135-878c-9b304d8cea7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gendex GXS-700™ intraoral sensor sheaths
• Version Model Number: 1.008.1086
• Catalog Number: 112 1433G1
• Company DUNS: 144575763
• Company Name: GENDEX CORP.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• 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 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	0EKAV100810860 [Unit of Use]
HIBCC	EKAV100810860 [Primary]

FDA Product Code

• MMP: Cover, barrier, protective

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

Devices Manufactured by GENDEX CORP.

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• EKAV101291590 - KaVo GXS-700™ intraoral sensor: 2022-01-31 Size 1 Kit
• EKAV101291600 - KaVo GXS-700™ intraoral sensor: 2022-01-31 Size 2 Kit
• EKAV101291610 - KaVo GXS-700™ intraoral sensor: 2022-01-31 Size 1, Size 2 Kit
• EKAV101305110 - KaVo GXS-700™ intraoral sensor: 2022-01-31 Size 1 Kit
• EKAV101305120 - KaVo GXS-700™ intraoral sensor: 2022-01-31 Size 1 Kit