ScanX Barrier Envelope, 300 Pcs, Size 2 73248-2

GUDID E247732482

Light protection covers for image plates (used with the ScanX image plate scanners).

DÜRR DENTAL SE

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• Primary Device ID: E247732482
• NIH Device Record Key: 14677706-e4de-4a70-af89-d0d146c87512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanX Barrier Envelope, 300 Pcs, Size 2
• Version Model Number: 300 Pcs, Size 2
• Catalog Number: 73248-2
• Company DUNS: 315563684
• Company Name: DÜRR DENTAL SE
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E247732482 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-07
• Device Publish Date: 2023-02-27

Devices Manufactured by DÜRR DENTAL SE

• E247732480 - ScanX Barrier Envelope, 100 Pcs, Size 0: 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
• E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 2: 2023-03-07Light protection covers for image plates (used with the ScanX image plate scanners).
• E247732482 - ScanX Barrier Envelope, 300 Pcs, Size 2: 2023-03-07 Light protection covers for image plates (used with the ScanX image plate scanners).
• E247G8800 - ScanX Swift 2.0: 2023-03-07 Dental Image Plate Scanner
• E247G8900 - ScanX Swift View 2.0: 2023-03-07 Dental Image Plate Scanner
• E247E7300A10 - VisionX: 2022-04-04 VisionX version 3.0.x
• E247A78610 - ProVecta 3D Prime Ceph: 2022-03-14 X-Ray System
• E247J21101 - CamX Elara: 2022-03-14
• E247J27111 - CamX Cam Interchangeable Head: 2022-03-14