SOF-CURL URETERAL STENT 6.0X28

GUDID 00821925005228

"5626028 SOF-CURL URETERAL STENT 6.0X28"

Gyrus Acmi, Inc.

Polymeric ureteral stent

• Primary Device ID: 00821925005228
• NIH Device Record Key: ec7262cd-24f5-423f-b89c-beb4bdd15c91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOF-CURL URETERAL STENT 6.0X28
• Version Model Number: 5626028
• 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	00821925005228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930733

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: 2016-10-12

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