AccessGUDID - DEVICE: TrueFlex Bolus (00860007402340)

GUDID

Device Identifier (DI) Information

Brand Name: TrueFlex Bolus
Version or Model: NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADPT-ONDEM-3DPRT-SIL
Company Name: Adaptiiv Medical Technologies Inc

Primary DI Number: 00860007402340
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203502513 *Terms of Use

Device Description: TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.

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):	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?
58021	Radiation therapy bolus, single-use	A pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a single-use device.	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 [?]
K243057	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: a250071b-b218-4262-940f-944b5babd555
Public Version Date: December 17, 2024
Public Version Number: 1
DI Record Publish Date: December 09, 2024