ScanX Barrier Envelopes

GUDID D678G851111

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: D678G851111
• NIH Device Record Key: 6c359f9b-c4ea-4f82-8f01-4eb3e139a8d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanX Barrier Envelopes
• Version Model Number: G8511-1
• Company DUNS: 043835081
• Company Name: AIR TECHNIQUES, INC.
• Device Count: 1
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-247-8324
• Email: xx@xx.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D678G851111 [Primary]

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: 2
• Public Version Date: 2020-01-20
• Device Publish Date: 2019-08-27

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.