RealCloud HD1

GUDID 00864058000326

HDTV intraoral camera

REALCLOUD IMAGING, INC.

Intraoral camera

• Primary Device ID: 00864058000326
• NIH Device Record Key: 3a5eb0eb-ddf1-4e12-94fa-5dac596e99f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RealCloud HD1
• Version Model Number: 1
• Company DUNS: 079879515
• Company Name: REALCLOUD IMAGING, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864058000326 [Primary]

FDA Product Code

• NRD: Unit, Operative Dental, Accessories

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: 2019-01-21
• Device Publish Date: 2018-12-20

Devices Manufactured by REALCLOUD IMAGING, INC.

• 00864058000302 - Dentrix Ascend Imaging: 2019-05-23 Web-based dental Picture Archiving and Communications System (PACS)
• 00864058000319 - Dentrix Smart Image: 2019-02-01 Dental Medical Device Data Systems (MDDS)
• 00864058000326 - RealCloud HD1: 2019-01-21HDTV intraoral camera
• 00864058000326 - RealCloud HD1: 2019-01-21 HDTV intraoral camera