PORTRAY 14-100000

GUDID 00850034901008

PORTRAY System - Extraoral Source X-ray System

Surround Medical Systems

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 00850034901008
• NIH Device Record Key: 3105df97-eeaf-4e50-8c5e-42988b5e2a90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PORTRAY
• Version Model Number: DW.30.00
• Catalog Number: 14-100000
• Company DUNS: 080829354
• Company Name: Surround Medical Systems
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850034901008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211014

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: 2021-12-23
• Device Publish Date: 2021-12-15

On-Brand Devices [PORTRAY]

• 00850034901077: X-Ray Detector
• 00850034901060: Detector Holders Kit
• 00850034901053: Detector Holder, Posterior, RH
• 00850034901046: Detector Holder, Posterior, LH
• 00850034901039: Detector Holder, Bite Wing
• 00850034901022: Detector Holder, Anterior
• 00850034901015: Coupler Ring w/ Magnets
• 00850034901008: PORTRAY System - Extraoral Source X-ray System
• 00850034901114: PORTRAY System - Extraoral Source X-ray System
• 00850034901107: PORTRAY System - Extraoral Source X-ray System
• 00850034901091: PORTRAY System - Extraoral Source X-ray System