Model: 205W10F40
DI: 06973356555057
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fb91abb1-e3f6-4233-b06f-4431e4fed47c
Distribution Status:
In Commercial Distribution
DUNS Number:
698045520
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:
06973356555057
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64309
Name: Ureteral introduction sheath
Definition:
A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.
FDA Product Codes
FED
Endoscopic Access Overtube, Gastroenterology-Urology
Premarket Submissions
Submission Number:
K243710
Supplement Number:
000