AccessGUDID - DEVICE: 1100 - Lumen Tray with Accessory Kit (00816634020136)

GUDID

Device Identifier (DI) Information

Brand Name: 1100 - Lumen Tray with Accessory Kit
Version or Model: 1100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ultra Clean Systems, Inc.

Primary DI Number: 00816634020136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010043227 *Terms of Use

Device Description: Model 1100 - Lumen Tray with Accessory Kit

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36749	Ultrasonic-cleaning water bath	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLG	Cleaner, Ultrasonic, Medical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 07fb0887-7114-4151-afba-af1cbb9ee744
Public Version Date: May 15, 2025
Public Version Number: 3
DI Record Publish Date: January 13, 2025