Dewan 020875

GUDID 00827002168909

Dewan Suprapubic Urodynamic Catheter Set

COOK INCORPORATED

Urodynamic measurement system

• Primary Device ID: 00827002168909
• NIH Device Record Key: 8bfdb789-ee8b-45b4-a3be-1730131a1db6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dewan
• Version Model Number: G16890
• Catalog Number: 020875
• Company DUNS: 042823948
• Company Name: COOK INCORPORATED
• 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: true
• 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(812)330-5494
• Email: sharedservices@cookmedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002168909 [Primary]

FDA Product Code

• FAP: CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE

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: 2016-09-24

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