Device
Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 1 per pack
Manufacturer
Liberty Medical , Inc.
Liberty Medical , Inc.
Model: 5764
DI: B16557640328043026081
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 1 per pack
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a06bb18d-d816-4f5e-a89d-cfff1b6078d7
Distribution Status:
In Commercial Distribution
DUNS Number:
967592978
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B16557640328043026081
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38435
Name: General-purpose brachytherapy system applicator, manual
Definition:
A general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.
FDA Product Codes
IWJ
System, Applicator, Radionuclide, Manual