Device
3in long with eyelets at both ends
Manufacturer
Marlen Manufacturing And Development Co.
Marlen Manufacturing And Development Co.
Model: 617
DI: 00661613006171
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-03
Current Version: 2026-05-11
Description
3in long with eyelets at both ends
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:
96ac876e-6b22-49e0-ab59-00dc47f32ef9
Distribution Status:
In Commercial Distribution
DUNS Number:
004220711
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00661613006171
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 31987
Name: Colostomy rod
Definition:
A device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device.
FDA Product Codes
EZP
Rod, Colostomy