AccessGUDID - DEVICE: Midmark Vantage Cephalometric Sensor (00841709102585)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark Vantage Cephalometric Sensor
Version or Model: 60-A1019
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-A1019
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709102585
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: Panoramic X-ray Assembly with Cephalometric Extension with no sensor

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):	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?
43620	Stationary cephalometric x-ray system, digital	A stationary cephalometric x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through a patient's head (skull). It is used for: 1) radiographic visualization and measurement of the dimensions of the human head, e.g., abnormal structures of the skull; 2) orthodontic assessment of the relationship of the teeth to the jaws and the jaws to the rest of the facial skeleton; 3) assessment airway and other soft tissue structures. The sensor is placed outside the head. The data is either from analogue imaging and digitized afterwards or by digital imaging.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUH	System,X-Ray,Extraoral Source,Digital

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K122643	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
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -35 and 66 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e89185a-7793-4147-b7ba-c0e7344a4eda
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016