AccessGUDID - DEVICE: Midmark PREVA IntraOral Dental X-ray System (00841709102523)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark PREVA IntraOral Dental X-ray System
Version or Model: 30-A1027
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30-A1027
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709102523
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: Intraoral X-ray Preva Tube Head With Oil

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?
35618	X-ray tube housing assembly, diagnostic	A metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHD	Unit, X-Ray, Extraoral With Timer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K043092	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: 024ded36-9b29-4f75-8ebd-d6cfc459ec8a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016