AccessGUDID - DEVICE: Midmark Progeny Imaging Software (00841709101380)

GUDID

Device Identifier (DI) Information

Brand Name: Midmark Progeny Imaging Software
Version or Model: 45-A0023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45-A0023
Company Name: MIDMARK CORPORATION

Primary DI Number: 00841709101380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005036025 *Terms of Use

Device Description: X-ray system application software

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?
40876	General-purpose dental x-ray system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose dental x-ray system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some application software routines or groups of routines (packages) must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	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 [?]
K070664	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b3ca5b76-c95b-4b95-b3e9-fb32a2d5b78d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016