AccessGUDID - DEVICE: Provecta HD Single Post Mounting Plate (D678A63890)

GUDID

Device Identifier (DI) Information

Brand Name: Provecta HD Single Post Mounting Plate
Version or Model: A6389
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AIR TECHNIQUES, INC.

Primary DI Number: D678A63890
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 043835081 *Terms of Use

Device Description: The Provecta HD Single Post Mounting Plate is used to secure the Provecta HD X-ray unit onto a facility wall with 4"x4" wood wall studs or a single or double 2"x4".

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:	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?
65120	Custom-made medical device mount	A structure intended to be permanently-fixed to the ceiling and/or wall to support/stow a medical device(s) [e.g., light, monitor, surgical instruments] or stow/provide medical supplies. It is designed with specific characteristics as requested by a healthcare professional to meet the requirements of a specific facility. It may incorporate a pole, rack, shelves, electricity supply sockets, gas outlets, and/or enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device(s) to be mounted is not included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYB	Tube Mount, X-Ray, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: a3246799-c0af-4693-8dda-c43bbe909177
Public Version Date: July 19, 2023
Public Version Number: 1
DI Record Publish Date: July 11, 2023