Uro-EZDilate 12Fr (4mm) x 10cm

GUDID 00821925033061

Gyrus Acmi, Inc.

Ureteral dilatation catheter

• Primary Device ID: 00821925033061
• NIH Device Record Key: 13294e81-9534-467e-8f27-004db24d2e4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uro-EZDilate 12Fr (4mm) x 10cm
• Version Model Number: BURS0410
• 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	00821925033061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132181

FDA Product Code

• KOE: DILATOR, URETHRAL

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: 2016-10-05

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