DEVICE: Visionary by 3D Dental (00817169025221)
Device Identifier (DI) Information
Visionary by 3D Dental
XBAP2
In Commercial Distribution
XBAP2
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
XBAP2
In Commercial Distribution
XBAP2
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
VISIONARY PREMIUM BARRIER ENVELOPE #2 300/BX WITH EXTENDED TAB
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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45256 | Digital imaging cassette/storage phosphor screen, dental |
A combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EGZ | Holder, Film, X-Ray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
293cb255-6a33-4ccd-81e6-131900f4ef4c
January 18, 2023
1
January 10, 2023
January 18, 2023
1
January 10, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined