1150 - Lumen Tray with Accessory Kit

GUDID 00816634020143

Model 1150 - Lumen tray with Accessory kit

Ultra Clean Systems, Inc.

Ultrasonic-cleaning water bath
Primary Device ID00816634020143
NIH Device Record Keya1701391-eaf0-402c-8bd7-99bd7d581788
Commercial Distribution StatusIn Commercial Distribution
Brand Name1150 - Lumen Tray with Accessory Kit
Version Model Number1150
Company DUNS010043227
Company NameUltra Clean Systems, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816634020143 [Primary]

FDA Product Code

FLGCleaner, Ultrasonic, Medical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-21
Device Publish Date2025-01-13

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