AccessGUDID - DEVICE: Phosphor Storage Plate Guide Size 1 (D6787356611)

GUDID

Device Identifier (DI) Information

Brand Name: Phosphor Storage Plate Guide Size 1
Version or Model: 73566-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D6787356611
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: An accessory used to help guide the phosphor storage plate used in our ScanX Digital Radiography Device System.

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?
31828	Dental x-ray system beam alignment device	A mechanical device that is used to support and position dental x-ray film and to serve as a guide for proper physical alignment of the x-ray tube with the positioned dental x-ray film during dental x-ray imaging procedures. Depending on the device design, it can be used as a guide for either intraoral or extraoral dental x-ray systems.	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: 0839f321-93d6-4494-a9db-9fb71e732b58
Public Version Date: July 09, 2018
Public Version Number: 1
DI Record Publish Date: June 08, 2018