BERKELEY

GUDID 00821925038196

BERKELEY 1/2" (13 mm) PRIMARY COLLECTION BOTTLES (10/PK)

Gyrus ACMI, LLC

Surgical suction system collection container, single-use

• Primary Device ID: 00821925038196
• NIH Device Record Key: e1e656d7-4918-42f7-a27d-a63d97f31e4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BERKELEY
• Version Model Number: BKC-506
• 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	00821925038196 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 10
• Public Version Date: 2024-11-15
• Device Publish Date: 2016-10-13

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• 00821925047150 - Olympus: 2025-09-29 ES-IP DUAL IN-ROOM System - EXPANDED 48U
• 00821925047242 - Olympus: 2025-09-29 ES-IP iOR BWK Hamburg ER (with rack)
• 00821925047259 - Olympus: 2025-09-29 ES-IP iOR BWK Hamburg ER (no rack)
• 00821925047266 - Olympus: 2025-09-29 ES-IP iOR BWK Hamburg OP (with rack)