AccessGUDID - DEVICE: ScanX Barrier Envelopes (D678G851121)

GUDID

Device Identifier (DI) Information

Brand Name: ScanX Barrier Envelopes
Version or Model: G8511-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678G851121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients.

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):	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?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental Barriers And Sleeves

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: 1c9b6fad-193d-4213-9e56-a6aa15b40122
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 09, 2023