Model: 180-60
DI: 00841365121562
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
076d767a-857c-4611-938e-048695d53665
Distribution Status:
In Commercial Distribution
DUNS Number:
086352655
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00841365121562
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38436
Name: General-purpose brachytherapy system applicator, remote-afterloading
Definition:
A general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].
FDA Product Codes
IWJ
System, Applicator, Radionuclide, Manual
Premarket Submissions
Submission Number:
K904933
Supplement Number:
000