Model 1101

GUDID 00816634020037

Ultrasonic Cleaning System - Model 1101

Ultra Clean Systems, Inc.

Ultrasonic-cleaning water bath

• Primary Device ID: 00816634020037
• NIH Device Record Key: 9ee3eb5f-8df1-4068-bfa0-3ae286b05875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Model 1101
• Version Model Number: 1101
• Company DUNS: 010043227
• Company Name: Ultra Clean Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816634020037 [Primary]

FDA Product Code

• FLG: Cleaner, Ultrasonic, Medical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-27
• Device Publish Date: 2024-12-19

Devices Manufactured by Ultra Clean Systems, Inc.

• 00816634020396 - Xi Adapter: 2025-07-17 X/Xi 1101 Adapters - 6/PK X/Xi Triton Adapters - 10/PK
• 00816634020464 - Xi Adapter R2: 2025-07-17
• 00816634020488 - D5 Adapter: 2025-07-17
• 00816634020440 - SP Adapter: 2025-07-17 SP Adapter - 8/pk
• 10816634020263 - 1101 - Xi RACS tray with adapters (6): 2025-05-15 Xi RACS tray with adapters (6) for Model 1101
• 00816634020358 - Hospital wire mesh tray: 2025-04-04 Hospital wire mesh tray
• 20816634020079 - Sanizyme 2.5-Gallon: 2025-03-12 Sanizyme 2.5-Gallon, 2 pack
• 10816634020096 - Sanizyme 15-Gallons: 2025-03-12 Sanizyme 15-Gallons