4.5FR (1.49mm) X 10 cm Double Pigtail URETERAL STENT HYDROPHILIC COATED TECOFLEX

GUDID 00821925002883

Serving as a temporary indwelling catheter.

Gyrus Acmi, Inc.

Polymeric ureteral stent

• Primary Device ID: 00821925002883
• NIH Device Record Key: 91e05920-956c-4824-9937-646c9ffc25ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.5FR (1.49mm) X 10 cm Double Pigtail URETERAL STENT HYDROPHILIC COATED TECOFLEX
• Version Model Number: 5604510
• 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	00821925002883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960148

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: 2015-10-24

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