Device
A sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or...
Manufacturer
ASSOMEDIKA, OOO
ASSOMEDIKA, OOO
Model: 1201 200 025
DI: 04816415501072
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-19
Current Version: 2026-05-27
Description
A sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or pancreatic tract via the sphincter of Oddi, and terminate proximally via the nasal passage; devices associated with catheter introduction/connection (excluding the endoscope) may be included (e.g., nasal transfer tube, drainage connecting tube, guidewire), however it does not include any fluid collection bags/containers. This is a single-use device.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0a79a965-1f46-48a2-a0ce-57cc3a5439be
Distribution Status:
In Commercial Distribution
DUNS Number:
683522555
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:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
04816415501072
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47059
Name: Nasal biliary/pancreatic drainage catheter
Definition:
A sterile, flexible tube intended to be introduced endoscopically for the temporary drainage of the biliary and/or pancreatic duct. It is intended to navigate to the biliary and/or pancreatic tract via the sphincter of Oddi, and terminate proximally via the nasal passage; devices associated with catheter introduction/connection (excluding the endoscope) may be included (e.g., nasal transfer tube, drainage connecting tube, guidewire), however it does not include any fluid collection bags/containers. This is a single-use device.
FDA Product Codes
GCD
Connector, Catheter