Model: 10113-46-3
DI: 00841365121531
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
29896c4b-6552-45e2-99e0-e4cc3b54395b
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00841365121531
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 33069
Name: Brachytherapy injection needle
Definition:
A sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.
FDA Product Codes
KXK
Source, Brachytherapy, Radionuclide
Premarket Submissions
Submission Number:
K043117
Supplement Number:
000