Device
Large Manifold to be used with LumenEye X1
Manufacturer
SURGEASE INNOVATIONS LIMITED
SURGEASE INNOVATIONS LIMITED
Model: LX1-LMB-261
Catalog: LX1-LMB-261
DI: 05060768280736
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Description
Large Manifold to be used with LumenEye X1
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
83cdfc5d-d9ff-427b-ad41-c17a6d90229c
Distribution Status:
In Commercial Distribution
DUNS Number:
221628713
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
CARTON
Item #1 - Device ID:
05060768280743
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05060768280736
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05060768280736
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63564
Name: Endoscope sheath, single-use
Definition:
A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a single-use device.
FDA Product Codes
FAN
Sigmoidoscope, Rigid, Electrical
Premarket Submissions
Submission Number:
K232262
Supplement Number:
000