Model: Model 1101 - Lumen Tray with Accessory kit
DI: 07340153715950
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0bd477a7-05e2-4e58-91f8-f83ff3cad0d0
Distribution Status:
In Commercial Distribution
DUNS Number:
354023236
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
07340153715950
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36749
Name: Ultrasonic-cleaning water bath
Definition:
An electrically-powered device intended to be used to clean instruments/utensils with ultrasonic waves transmitted from its integral transducers through water contained in a bath. A dedicated cleaning agent may be added to the water to enhance the cleaning effect.
FDA Product Codes
FLG
Cleaner, Ultrasonic, Medical Instrument