SureCath 28006

GUDID 05708932639774

SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 10/3.3 mm. Vol 700

Coloplast A/S

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 05708932639774
• NIH Device Record Key: 757c9626-ccaa-4cf0-a345-988b10283e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureCath
• Version Model Number: 28006
• Catalog Number: 28006
• 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

• Total Volume: 700 Milliliter
• Catheter Gauge: 10 French
• Length: 40 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.3 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05708932021036 [Primary]
GS1	05708932639774 [Package]; Contains: 05708932021036; 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

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