Model: 197230FLA
DI: B390197230FLA1
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
4mm EndoScrub Sheath, 45 deg, K Storz
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9986b967-5e0e-4aab-943b-6119b4b7a8f3
Distribution Status:
In Commercial Distribution
DUNS Number:
785616934
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B390197230FLA1
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 48141
Name: Paranasal sinus irrigation catheter
Definition:
A flexible tube designed to introduce fluid (e.g., saline solution) into the sinus cavities to provide irrigation for the flushing and removal of mucus, pus, and blood from the site of intervention. It typically consists of a single-lumen tube with end and/or side holes at the distal end; the proximal end is typically connected to a syringe or irrigation fluid pumping system via a Luer-lock. This is a single-use device.
FDA Product Codes
KAM
Cannula, Sinus