AccessGUDID - DEVICE: Protect-A-Grid (00860001700183)

GUDID

Device Identifier (DI) Information

Brand Name: Protect-A-Grid
Version or Model: P[2][X]DR[NG][Y]
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Premium Grid Encasement
Company Name: Reina Imaging

Primary DI Number: 00860001700183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102370137 *Terms of Use

Device Description: The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. "

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?
40915	Stationary x-ray grid	A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXY	Holder, Radiographic Cassette, Wall-Mounted

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: 056c1e48-1baf-49cb-9acc-cec585dd53a5
Public Version Date: November 06, 2019
Public Version Number: 1
DI Record Publish Date: October 29, 2019