Gendex GXS-700™ intraoral sensor 112 1434G1

GUDID EKAV100810810

Size 2, 100 Count

GENDEX CORP.

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

• Primary Device ID: EKAV100810810
• NIH Device Record Key: 15a76537-df30-4a3f-87b6-2ff047bebb63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gendex GXS-700™ intraoral sensor
• Version Model Number: 1.008.1081
• Catalog Number: 112 1434G1
• 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	0EKAV100810810 [Unit of Use]
HIBCC	EKAV100810810 [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

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