AccessGUDID - DEVICE: Medium Prostate Brachytherapy Kit (B16558010325093023190)

GUDID

Device Identifier (DI) Information

Brand Name: Medium Prostate Brachytherapy Kit
Version or Model: 5801
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Liberty Medical , Inc.

Primary DI Number: B16558010325093023190
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967592978 *Terms of Use

Device Description: The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy

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?
38426	Prostate brachytherapy system applicator, manual	A manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWJ	System, Applicator, Radionuclide, Manual

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: Yes
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
Needle Gauge: 15 Gauge

Device Record Status

Public Device Record Key: 84a5bb59-1ef1-47eb-ac89-34e7492c3164
Public Version Date: November 24, 2023
Public Version Number: 1
DI Record Publish Date: November 16, 2023