United Urologics Insertion Kit

GUDID 10818016020311

UNITED UROLOGICS INC

Urethral catheterization support kit, urinary drainage

• Primary Device ID: 10818016020311
• NIH Device Record Key: 02d56bf0-63e7-4f6f-b14f-53023c5ae646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: United Urologics Insertion Kit
• Version Model Number: UUIK01
• Company DUNS: 080428707
• Company Name: UNITED UROLOGICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818016020314 [Primary]
GS1	10818016020311 [Package]; Contains: 00818016020314; Package: [100 Units]; In Commercial Distribution

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: 2019-04-09
• Device Publish Date: 2017-03-22

Devices Manufactured by UNITED UROLOGICS INC

• 00818016020635 - United Urologics Closed System Catheter: 2019-11-18
• 00818016020109 - United Urologics Closed System Catheter: 2019-11-18
• 10818016020311 - United Urologics Insertion Kit: 2019-04-09
• 10818016020311 - United Urologics Insertion Kit: 2019-04-09
• 00818016020017 - United Urologics Closed System Catheter Kit: 2018-03-29
• 00818016020024 - United Urologics Closed System Catheter: 2018-03-29
• 00818016020031 - United Urologics Closed System Catheter: 2018-03-29
• 00818016020048 - United Urologics Closed System Catheter: 2018-03-29
• 00818016020055 - United Urologics Closed System Catheter: 2018-03-29