Device
The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary trac...
Manufacturer
SEPLOU (ZHUHAI) CO.,LTD.
SEPLOU (ZHUHAI) CO.,LTD.
Model: SPAS1045S
DI: 06976358504320
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Distribution End: 2026-05-07
Description
The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2ac47a8f-6363-4480-8499-43d627cd008e
Distribution Status:
Not in Commercial Distribution
DUNS Number:
847378548
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06976358504320
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38821
Name: Endoscopic-access dilator, single-use
Definition:
A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.
FDA Product Codes
FED
Endoscopic Access Overtube, Gastroenterology-Urology