AccessGUDID - DEVICE: .decimal Proton Shell and Lid Assembly (00851147007083)

GUDID

Device Identifier (DI) Information

Brand Name: .decimal Proton Shell and Lid Assembly
Version or Model: 2.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DECIMAL, INC.

Primary DI Number: 00851147007083
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 9999
Device Count: 1
Labeler D-U-N-S® Number*: 617041967 *Terms of Use

Device Description: A reusable steel Shell & Lid (or material with similar attenuating properties) with a 2D hole cut from it which is where the custom Brass core is to be placed for treatment with a proton beam.

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?
42274	Radiation therapy beam block material	A material designed for creating a custom-made beam block used to size, shape, or control depth of penetration of a beam of radiation delivered to a patient during radiation therapy treatments, to limit or eliminate exposure to non-target body areas. Beam block material is either: 1) a highly attenuating material, e.g., lead, cerrobend (Wood’s metal), or Rose's metal (aperture type); or 2) a material such as acrylic or wax that can be used to control the beam energy delivery depth. It can be cut or moulded into specific configurations to shape/define/attenuate the radiation beam, and is typically remelted for reuse after the patient treatment is considered finished.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUJ	System,Planning,Radiation Therapy Treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132236	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: d32cdea0-1921-4596-b066-995fdfaa15b3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016