SureCath 28027

GUDID 05708932640381

SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 12/4.0 mm. Vol 1200

Coloplast A/S

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 05708932640381
• NIH Device Record Key: 477f50b5-030e-487f-9808-38e40969f76a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureCath
• Version Model Number: 28027
• Catalog Number: 28027
• Company DUNS: 305524696
• Company Name: Coloplast A/S
• 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

Customer Support Contacts

• Phone: +1(800)533-0464
• Email: healthcarecs@coloplast.com

Device Dimensions

• Catheter Gauge: 12 French
• Length: 40 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 4 Millimeter
• Total Volume: 1200 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if sterile barrier is damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932021104 [Primary]
GS1	05708932640381 [Package]; Contains: 05708932021104; Package: Shipper box [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973070

FDA Product Code

• EZD: CATHETER, STRAIGHT

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: 2016-09-02

On-Brand Devices [SureCath]

• 05708932640633: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640640: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640671: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640664: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932615884: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640619: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640596: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640343: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640336: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639835: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640428: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640411: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640404: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640381: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640367: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932640350: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639828: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639804: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639798: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639781: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639774: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic
• 05708932639767: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic