Gyrus ACMI

GUDID 00821925036147

5 FR Open End Ureteral Catheter 5.0 FR (1.667 mm) X 70 cm (10/PK)

Gyrus ACMI, LLC

Ureteral catheter

• Primary Device ID: 00821925036147
• NIH Device Record Key: a4ceb3fa-1e26-4762-b1ba-03e498f72c4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gyrus ACMI
• Version Model Number: 605BX
• 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: false
• Expiration Date: true
• 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	00821925008472 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	00821925036147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930483

FDA Product Code

• EYB: Catheter, Ureteral, Gastro-Urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-17
• Device Publish Date: 2024-12-09

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)