AccessGUDID - DEVICE: ScanX Barrier Envelope, 100 Pcs, Size 0 (E247732480)

GUDID

Device Identifier (DI) Information

Brand Name: ScanX Barrier Envelope, 100 Pcs, Size 0
Version or Model: 100 Pcs, Size 0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 73248-0
Company Name: DÜRR DENTAL SE

Primary DI Number: E247732480
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315563684 *Terms of Use

Device Description: Light protection covers for image plates (used with the ScanX image plate scanners).

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:	Yes
Prescription Use (Rx):	Yes
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?
66696	Dental digital imaging phosphor plate intraoral cover	An intraoral device in the form of an envelope or sleeve intended to cover a digital imaging phosphor plate prior to introduction into the oral cavity, to prevent cross-contamination between patients and/or shield the plate from ambient light. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental Barriers And Sleeves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190949	000

Device Exempt from Premarket Submission: No 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: 50b79668-569b-40bc-b8c7-3815e2c0e976
Public Version Date: January 31, 2025
Public Version Number: 2
DI Record Publish Date: February 27, 2023