AccessGUDID - DEVICE: Midmark PREVA IntraOral Dental X-ray System (00841709101731)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark PREVA IntraOral Dental X-ray System
Version or Model: DCD6DE-W2X/H/S2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DCD6DE-W2X/H/S2
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709101731
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

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:	Yes
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?
42279	Mobile specimen x-ray system, analogue	A mobile (on wheels) specimen x-ray system designed to generate and control x-ray beams and to record the absorption patterns of x-rays passing through tissue samples or amputated body parts. The image is from film or phosphor plate.	Obsolete	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: 310fca99-a18a-4c70-b5be-a11d0bdd664c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016