Rutner 013250

GUDID 00827002145399

Rutner Balloon Dilation Helical Stone Extractor

COOK INCORPORATED

Stone/foreign-body extraction set

• Primary Device ID: 00827002145399
• NIH Device Record Key: d8eb3ca1-9a71-4af2-a42e-9731d572d678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rutner
• Version Model Number: G14539
• Catalog Number: 013250
• 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
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002145399 [Primary]

FDA Product Code

• FFL: DISLODGER, STONE, BASKET, URETERAL, METAL

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: 2016-11-04

On-Brand Devices [Rutner]

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• 00827002149205: Rutner Suprapubic Balloon Catheter Set
• 00827002146815: Rutner Balloon Dilation Helical Stone Extractor
• 00827002145474: Rutner Balloon Dilation Helical Stone Extractor
• 00827002145405: Rutner Balloon Dilation Helical Stone Extractor
• 00827002145399: Rutner Balloon Dilation Helical Stone Extractor
• 00827002143142: Rutner Balloon Dilation Helical Stone Extractor
• 00827002142633: Rutner Balloon Dilation Helical Stone Extractor
• 10827002140575: Rutner Universal Wedge Catheter
• 10827002140568: Rutner Universal Wedge Catheter
• 00827002261242: Rutner Balloon Dilation Helical Stone Extractor
• 00827002173200: Rutner Suprapubic Balloon Catheter Set
• 00827002173194: Rutner Suprapubic Balloon Catheter Set
• 00827002165670: Rutner Suprapubic Balloon Catheter Set
• 00827002165663: Rutner Suprapubic Balloon Catheter Set
• 00827002165656: Rutner Suprapubic Balloon Catheter Set
• 00827002161986: Rutner Suprapubic Balloon Catheter Set