SAFETOUCH

GUDID 00821925037892

SAFETOUCH Collection System, 3/8" (9.5 mm) (10/PK)

Gyrus ACMI, LLC

Surgical suction system collection container, single-use

• Primary Device ID: 00821925037892
• NIH Device Record Key: d7a0fede-657d-4731-91f1-dd5dbc23f357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFETOUCH
• Version Model Number: 003987-901
• 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	00821925000230 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	00821925037892 [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: 2024-11-15
• Device Publish Date: 2016-10-07

Devices Manufactured by Gyrus ACMI, LLC

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• 00821925045996 - Olympus: 2025-04-17 nCare 4K Cable Assembly, 1694F, 3G-SDI, 4K BNC Male to Male, 6 ft. or (1.83 m), Black
• 00821925046610 - Olympus: 2025-04-17 nCare 4K Keyboard, All-in-one, Compact, Medical, Washable, USB, White
• 00821925047075 - Olympus: 2025-04-17 nCare 4K Footswitch
• 00821925047082 - Olympus: 2025-04-17 nCare 4K Audio Cables
• 00821925045941 - Olympus: 2025-04-16 nCare 4K 21.5" Medical Touch Panel
• 00821925045958 - Olympus: 2025-04-16 nCare 4K Cable Assembly, DVI-D to DVI-D, Single Link TMDS, Black, 6.0 ft. or (1.83 m)
• 00821925045965 - Olympus: 2025-04-16 nCare 4K Cable Assembly, HDMI M to DVI-D M, Single Link, Black, 6 ft. or (1.83 m)