Intraskan DC Plus

GUDID 08904269400446

Intraskan DC Plus with 15" Support tube is High Frequency Extra oral X-Ray source to be used for Intra oral X-Ray in Dental Radiography for diagnostic purpose.

SKANRAY TECHNOLOGIES PRIVATE LIMITED

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• Primary Device ID: 08904269400446
• NIH Device Record Key: 7a642618-8ac9-4016-a3b7-cd8733033322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intraskan DC Plus
• Version Model Number: 303-000134-24
• Company DUNS: 863358955
• Company Name: SKANRAY TECHNOLOGIES PRIVATE LIMITED
• 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: false
• Lot Batch: false
• 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
GS1	08904269400446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170967

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2019-10-04
• Device Publish Date: 2019-09-26

On-Brand Devices [Intraskan DC Plus]

• 08904269400446: Intraskan DC Plus with 15" Support tube is High Frequency Extra oral X-Ray source to be used for
• 08904269400453: Intraskan DC Plus with 24" Support tube is High Frequency Extra oral X-Ray source to be used for
• 08904269400477: Intraskan DC Plus Floor stand is High Frequency Extra oral X-Ray source to be used for Intra ora
• 08904269400460: Intraskan DC Plus with 33" Support tube is High Frequency Extra oral X-Ray source to be used for