Gyrus ACMI

GUDID 00821925017979

STRAIGHT VENT TUBE FLPL .045", TWIN PACK (60/PK)

Gyrus ACMI, LLC

Tympanostomy tube

• Primary Device ID: 00821925017979
• NIH Device Record Key: 68812ce8-d2d1-4301-b4da-ef2b9adf4b6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gyrus ACMI
• Version Model Number: 145703
• Company DUNS: 007198742
• Company Name: Gyrus ACMI, LLC
• Device Count: 2
• 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	00821925017979 [Package]; Contains: 00821925032965; Package: pack [60 Units]; In Commercial Distribution
GS1	00821925032965 [Primary]
GS1	00821925034662 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992222

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-02
• Device Publish Date: 2024-07-11

On-Brand Devices [Gyrus ACMI]

• 00821925017979: STRAIGHT VENT TUBE FLPL .045", TWIN PACK (60/PK)
• 00821925037908: Gauze Sack and O-Ring (10/PK)
• 00821925030831: Blu Epistaxis Pack, Large 10.0 cm x 1.5 cm x 2.5 cm, Bacteriostatic (10/PK)
• 00821925027329: E-Z GRIP GUIDEWIRE TORQUE DEVICE (5/PK)
• 00821925036147: 5 FR Open End Ureteral Catheter 5.0 FR (1.667 mm) X 70 cm (10/PK)
• 00821925002630: Fluid Pouch Disposable (12/PK)
• 00821925007932: Replacement Knob Assembly (4/PK)