Device
Single-use endoscopic suction and irrigation set intended for anorectal endoscopic procedures with compatible endoscopic systems. The device facilitates controlled irrigation and s...
Manufacturer
SURGEASE INNOVATIONS LIMITED
SURGEASE INNOVATIONS LIMITED
Model: SIS-CSB-101
DI: 05060768280576
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-18
Description
Single-use endoscopic suction and irrigation set intended for anorectal endoscopic procedures with compatible endoscopic systems. The device facilitates controlled irrigation and suction to assist visualization during procedures.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7bad6243-b690-4fc4-b1c9-16114bcb2003
Distribution Status:
In Commercial Distribution
DUNS Number:
221628713
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
05060768280576
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Carton
Item #2 - Device ID:
05060768280583
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
10
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
05060768280576
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 16779
Name: Suction/irrigation tubing, single-use
Definition:
A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.
FDA Product Codes
FCZ
Tube, Smoke Removal, Endoscopic
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
40
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
20
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
95
Item #2 - Storage Handling Type:
Storage Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
700
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
1060
Item #3 - Storage Handling Type:
Storage Environment Atmospheric Pressure