AccessGUDID - DEVICE: LiquiPhil™ (00812266030734)

GUDID

Device Identifier (DI) Information

Brand Name: LiquiPhil™
Version or Model: TLP211
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TLP211
Company Name: Providus Holdings, Inc.

Primary DI Number: 00812266030734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 104162493 *Terms of Use

Device Description: Optional Tumor Vessel Inserts, 5mm Plug Holder, holds the 5mm plugs listed on the RANDO® price list. The 5mm plugs are designed for use with TLD chips, rods and powder. Five RAN235 plugs included.

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?
40624	Multi-modality therapeutic radiation phantom, anthropomorphic	A device consisting of preserved human or animal tissue, or a two or three-dimensional (3-D) tissue-equivalent model designed to simulate the functional, physical, or a combination of these characteristics of normal or diseased human organs. It is available in both fixed and variable designs and typically include holders for ionization chambers, dosimeters or radiation measurement instruments. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used for quantitative and subjective assessments of the performance of a radiation therapy treatment planning system (RTTPS) and therapeutic radiation delivery systems.	Active	false
40631	Multi-modality therapeutic radiation phantom, test object	A device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXG	Phantom, Anthropomorphic, Radiographic

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: 9318c55f-cf52-4744-81f7-982171b5da13
Public Version Date: May 13, 2024
Public Version Number: 1
DI Record Publish Date: May 03, 2024