United Urologics Closed System Catheter

GUDID 00818016020103

UNITED UROLOGICS INC

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 00818016020103
• NIH Device Record Key: 71a3d7cc-e4d7-43ba-9bf7-759e51e0acb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: United Urologics Closed System Catheter
• Version Model Number: UU16R
• Company DUNS: 080428707
• Company Name: UNITED UROLOGICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818016020103 [Primary]
GS1	10818016020106 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• KOD: Catheter, Urological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-03-22

On-Brand Devices [United Urologics Closed System Catheter]

• 00818016020154: UU16C
• 00818016020147: UU14C
• 00818016020130: UU12C
• 00818016020123: UU14S
• 00818016020116: UU12S
• 00818016020103: UU16R
• 00818016020093: UU14R
• 00818016020086: UU12R
• 00818016020079: UU18
• 00818016020062: UU16
• 00818016020055: UU14
• 00818016020048: UU12
• 00818016020031: UU10
• 00818016020024: UU08
• 00818016020109: UU16R
• 00818016020635: UU16R