AccessGUDID - DEVICE: .decimal Proton Aperture (00851147007007)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00851147007007
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: .decimal Proton Aperture is designed by the customer to block and shape a beam of radiation. Each aperture is custom and unique to the patient.

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:	Yes
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
IXI	Block, Beam-Shaping, Radiation Therapy

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: cf9d0ad8-bacc-4274-8c46-abbaade87bc3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016