Malecot 082212

GUDID 00827002143319

Malecot Nephrostomy Accessory Set

COOK INCORPORATED

Nephrostomy catheter

• Primary Device ID: 00827002143319
• NIH Device Record Key: 00c690ca-59a3-46d6-a881-6bc83b1710e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Malecot
• Version Model Number: G14331
• Catalog Number: 082212
• 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	00827002143319 [Primary]

FDA Product Code

• KOB: CATHETER, SUPRAPUBIC (AND ACCESSORIES)

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: 2015-10-24

On-Brand Devices [Malecot]

• 00827002151666: Malecot Catheter
• 00827002149991: Malecot Catheter
• 00827002149984: Malecot Catheter
• 00827002148277: Percutaneous Malecot Nephrostomy Set
• 00827002147959: Percutaneous Malecot Nephrostomy Set
• 00827002147928: Malecot Catheter
• 00827002147720: Malecot Nephrostomy Catheter/Stent Set
• 00827002147638: Malecot Catheter
• 00827002147133: Percutaneous Malecot Nephrostomy Set
• 00827002146990: Percutaneous Malecot Nephrostomy Set
• 00827002146457: Percutaneous Malecot Nephrostomy Catheter Set
• 00827002146440: Percutaneous Malecot Nephrostomy Catheter Set
• 00827002146433: Percutaneous Malecot Nephrostomy Catheter Set
• 00827002145375: Large Malecot Nephrostomy Accessory Set
• 00827002145368: Percutaneous Malecot Nephrostomy Set
• 00827002145269: Malecot Nephrostomy Catheter/Stent Set
• 00827002145238: Malecot Nephrostomy Accessory Set
• 00827002145108: Malecot Nephrostomy Catheter/Stent Set
• 00827002145016: Malecot Nephrostomy Catheter/Stent Set
• 00827002144897: Percutaneous Malecot Nephrostomy Set
• 00827002144880: Malecot Nephrostomy Accessory Set
• 00827002144545: Malecot Nephrostomy Catheter/Stent Set
• 00827002144378: Malecot Nephrostomy Catheter/Stent Set
• 00827002144316: Malecot Nephrostomy Catheter/Stent Set
• 00827002144132: Malecot Catheter
• 00827002144125: Malecot Catheter
• 00827002143586: Percutaneous Malecot Nephrostomy Set
• 00827002143579: Percutaneous Malecot Nephrostomy Set
• 00827002143524: Percutaneous Malecot Nephrostomy Set
• 00827002143333: Large Malecot Nephrostomy Accessory Set
• 00827002143326: Large Malecot Nephrostomy Accessory Set
• 00827002143319: Malecot Nephrostomy Accessory Set
• 00827002143302: Malecot Nephrostomy Accessory Set
• 00827002141810: Percutaneous Malecot Nephrostomy Set
• 00827002169272: Silicone Malecot Catheter
• 00827002169265: Silicone Malecot Catheter
• 00827002169258: Silicone Malecot Catheter
• 00827002169241: Silicone Malecot Catheter
• 00827002169234: Silicone Malecot Catheter
• 00827002169227: Silicone Malecot Catheter
• 00827002169210: Silicone Malecot Catheter
• 00827002169203: Silicone Malecot Catheter
• 00827002169197: Silicone Malecot Catheter
• 00827002167148: Percutaneous Malecot Nephrostomy Set