AccessGUDID - DEVICE: Phosphor Storage Plate IDX S0 (E247G38100)

GUDID

Device Identifier (DI) Information

Brand Name: Phosphor Storage Plate IDX S0
Version or Model: G3810
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DÜRR DENTAL SE

Primary DI Number: E247G38100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315563684 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 278fdbd7-eea7-402b-b310-c32d060a16f5
Public Version Date: January 31, 2025
Public Version Number: 2
DI Record Publish Date: September 19, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
E247G36201	2	E247G38100		In Commercial Distribution
E247G36301	2	E247G38100		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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