DEVICE: Darby Dental Supply, LLC (00889813062012)

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Device Record History
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Device Identifier (DI) Information
Darby Dental Supply, LLC
5252545
In Commercial Distribution

DARBY DENTAL SUPPLY, LLC
00889813062012
GS1

4
825137818 *Terms of Use
PHOSPHR IMGE PLATE GENDEX SZ2
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
67230 Digital imaging phosphor plate, dental, intraoral
A thin, photostimulable, dental device intended to be placed in an appropriate cover (not included), and subsequently introduced into the oral cavity and exposed to radiation by a diagnostic imaging x-ray system to record a radiation pattern of a patient’s teeth and/or jaws. Following exposure, it is transferred, typically in a light-shielding container (not included), to a computed radiography scanner (CR) to produce a digital image of the latent image formed on the plate. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EAM Screen, intensifying, radiographic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
fe380470-5a97-4daf-a0ab-8e1004909f4b
September 05, 2024
1
August 28, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 10889813062019 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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