ScanX Barrier Envelopes

GUDID D6787324801

An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients.

AIR TECHNIQUES, INC.

Digital imaging cassette/storage phosphor screen, dental

• Primary Device ID: D6787324801
• NIH Device Record Key: 62bcc2ee-05fd-406a-ac84-80050739c83c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanX Barrier Envelopes
• Version Model Number: 73248-0
• Company DUNS: 043835081
• Company Name: AIR TECHNIQUES, INC.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com
• Phone: +1 (516) 214-5512
• Email: mardonio.nicolas@airtechniques.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D6787324801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190949

FDA Product Code

• PEM: Dental Barriers And Sleeves

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-13
• Device Publish Date: 2019-08-23

On-Brand Devices [ScanX Barrier Envelopes]

• D678G851141: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. T
• D678G851131: An envelope tha tprovides a barrier against fluid to protect PSP plates used for X-ray images.
• D678G85112K1: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D678G851111: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D678G851101: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D6787324841: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D6787324831: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D678732482K1: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D6787324821: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D6787324811: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D678G85112C1: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D678G851121: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.
• D6787324801: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images.