AccessGUDID - DEVICE: A/T 2000 XR Intraoral Film Processor (D678450000)

GUDID

Device Identifier (DI) Information

Brand Name: A/T 2000 XR Intraoral Film Processor
Version or Model: 45000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678450000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: The A/T 2000 XR Intraoral Film Processor provides high quality radiographs in any size such as Panoramic, Cephalometric, TMJ, Occlusal and all Intraorals. Includes: 1 levelling base, 1 bottle spray 2000 Plus; 4 Air Techniques cleaning films; 1 instructional DVD: 1 case chemistry, 1 bottle of starter.

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:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15939	Dental automated x-ray film processor	A mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design.	Active	false

FDA Product Code

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Product Code	Product Code Name
IXW	Processor, Radiographic-Film, Automatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001321	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
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 75 Pound
Width: 14.25 Inch
Height: 15 Inch
Depth: 26 Inch

Device Record Status

Public Device Record Key: 1bbdcc53-d70f-48aa-acb6-f4327d4effea
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016