Model: LX1-CCS-202
Catalog: LX1-CCS-202
DI: 05060768280040
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
Consumable Pack used with LumenEye X1
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0077adfb-1969-440b-94b2-1bb68b6b8abe
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:
05060768280712
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
25
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
05060768280040
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
05060768280040
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
FAN
Sigmoidoscope, Rigid, Electrical
Premarket Submissions
Submission Number:
K232262
Supplement Number:
000