Uro-EZDilate 18Fr (6mm) x 4cm

GUDID 00821925033122

Gyrus Acmi, Inc.

Ureteral dilatation catheter

• Primary Device ID: 00821925033122
• NIH Device Record Key: 4b32d9a8-a296-47a7-9316-e769f0f6716b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uro-EZDilate 18Fr (6mm) x 4cm
• Version Model Number: BURS0604
• 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	00821925033122 [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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