Silicone Foley Catheters

GUDID 00616784507835

DYNAREX CORPORATION

Indwelling urethral drainage catheter

• Primary Device ID: 00616784507835
• NIH Device Record Key: 16556942-cb51-4937-a05d-54f2b8ea5618
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Foley Catheters
• Version Model Number: 5078
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784507811 [Unit of Use]
GS1	00616784507828 [Primary]
GS1	00616784507835 [Package]; Contains: 00616784507828; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-07-12
• Device Publish Date: 2016-09-24

On-Brand Devices [Silicone Foley Catheters]

• 00616784508931: 5089
• 00616784508832: 5088
• 00616784508733: 5087
• 00616784508634: 5086
• 00616784508535: 5085
• 00616784508436: 5084
• 00616784508337: 5083
• 00616784508238: 5082
• 00616784508139: 5081
• 00616784508030: 5080
• 00616784507934: 5079
• 00616784507835: 5078
• 00616784507736: 5077
• 00616784507637: 5076
• 00616784507538: 5075
• 00616784507439: 5074