UROPASS II,6.0x10cm

GUDID 00821925005365

Gyrus Acmi, Inc.

Polymeric ureteral stent

• Primary Device ID: 00821925005365
• NIH Device Record Key: e788d40b-2ba5-455b-9fb7-2a4a43a1aed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UROPASS II,6.0x10cm
• Version Model Number: 5436010
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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	00821925005365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832915

FDA Product Code

• FAD: STENT, URETERAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-03

Devices Manufactured by Gyrus Acmi, Inc.

• 00821925028784 - USA Elite: 2024-07-22 USA Elite System M3 Autoclavable Retrograde Telescope 110 Degrees, Color Coded Red
• 00821925028869 - FALOPE-RING: 2024-07-22 FALOPE-RING BAND GUIDE KIT W/ 1-Band Guide, 2-Band Dilators & 6-O Rings
• 00821925028913 - Gyrus ACMI: 2024-07-22 Single Incision Inner Tube Assembly
• 00821925044630 - Gyrus ACMI: 2024-07-22 DURAVENT VENTILATION TUBE WITH TWIN SPOON FLANGES 1.27 MM I.D. BLUE SILICONE TAPERED LUMEN
• 00821925000292 - SURGIFLEX: 2024-07-15 SURGIFLEX Suction-Irrigating Probe Reusable Electrode w/Luer Lok Connector Spatula, 5 mm X 32 cm
• 00821925015708 - Gyrus ACMI: 2024-06-18 SCHUKNECHT CRESCENT FLUOROPLASTIC
• 00821925041394 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 0, UNI. LIGHT INSTACLEAR
• 00821925041400 - InstaClear: 2024-04-30 SHEATH, LENS CLEANER ULTRA 30DEG, TOP LIGHT INSTACLEAR