Renal Dilator/Sheath Set 8.0 FR (2.667 mm) - 30FR (10 mm)

GUDID 00821925009875

Gyrus Acmi, Inc.

Ureteral catheter

• Primary Device ID: 00821925009875
• NIH Device Record Key: 871907df-b60a-4b51-8f86-ea0789171e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renal Dilator/Sheath Set 8.0 FR (2.667 mm) - 30FR (10 mm)
• Version Model Number: 6830
• 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	00821925009875 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-05-10

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