CG799 5154257

GUDID 60192155154256

SIZE C COLLIMAT. FOR I/O XRAY UNITS

CARESTREAM DENTAL LLC

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• Primary Device ID: 60192155154256
• NIH Device Record Key: 1084b9ab-a4c1-4bc1-8f17-e5a34a93f258
• Commercial Distribution Discontinuation: 2020-02-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CG799
• Version Model Number: CG799
• Catalog Number: 5154257
• Company DUNS: 019796106
• Company Name: CARESTREAM DENTAL LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	60192155154256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060292

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-10
• Device Publish Date: 2018-01-15

Devices Manufactured by CARESTREAM DENTAL LLC

• 60192155945076 - RIOSensor+: 2024-01-25 RIOSensor+ Size 1
• 60192155945083 - RIOSENSOR+: 2024-01-25 RIOSENSOR+ SIZE 2
• 60192155944864 - CS 8200 3D Access: 2023-12-20 CS 8200 3D ACCESS
• 60192155944833 - DENTRA III: 2023-06-12 DENTRA III SIZE 1
• 60192155944840 - DENTRA III: 2023-06-12 DENTRA III SIZE 2
• 60192155944543 - Swissmeda powered by Carestream Dental: 2022-10-31 Swissmeda powered by Carestream Dental
• 60192155943720 - CS 3800 Wired: 2022-02-21 CS 3800 3D I/O SCANNER WIRED
• 60192155944482 - CS Model+: 2021-11-15 LICENCE CS MODEL+ V5 ALIGNER CAPABILITY