BERKELEY SAFE-TOUCH

GUDID 00821925037861

BERKELEY SAFE-TOUCH TISSUE TRAP (10/PK)

Gyrus ACMI, LLC

Surgical suction system collection container, single-use

• Primary Device ID: 00821925037861
• NIH Device Record Key: 106ee69e-e145-4b7f-95cd-0970694af7f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BERKELEY SAFE-TOUCH
• Version Model Number: 003853-902
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925000032 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	00821925037861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171440

FDA Product Code

• HHK: Curette, Suction, Endometrial (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2025-01-16
• Device Publish Date: 2016-10-07

Devices Manufactured by Gyrus ACMI, LLC

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• 00810008185155 - Olympus: 2025-01-30 ES-IP BASE SYSTEM, SPLIT RACK, THREE ROOM with Optional Equipment
• 00810008185162 - Olympus: 2025-01-30 ES-IP BASE SYSTEM, SPLIT RACK, FREESTANDING OPTION with Optional Equipment
• 00810008185261 - Olympus: 2025-01-30 ES-IP Dual IN-ROOM System with Optional Equipment
• 00810008185278 - Olympus: 2025-01-30 ES-IP EXPANDED IN-ROOM System 25RU with Optional Equipment
• 00810008185759 - Olympus: 2025-01-30 ES-IP Dual IN-ROOM System - Expanded with Optional Equipment