Model: IIS472
DI: M936IIS4721
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
IsoSphere, 4cm, 72 seeds
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b7be69a8-cd52-4819-b74e-74de3843dbc2
Distribution Status:
In Commercial Distribution
DUNS Number:
002751241
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
M936IIS4721
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 38303
Name: Manual brachytherapy source, permanent implant
Definition:
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
FDA Product Codes
KXK
Source, Brachytherapy, Radionuclide
Premarket Submissions
Submission Number:
K242818
Supplement Number:
000