COOK

Basic Information

• Brand Name: COOK
• Primary DI: 10827002472836
• Version / Model: G47283
• Catalog Number: FLRSH-PEA
• Company Name: COOK INCORPORATED
• Labeler DUNS: 079720472
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-01
• Public Version: 2
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 11c4cf1d-b513-4753-a9e5-f9a06fd5b388
• Distribution End Date: 2023-07-12

Device Description

Flourish Pediatric Esophageal Atresia Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PTK	Pediatric esophageal atresia anastomosis device	Gastroenterology, Urology	876.5980	3

GMDN Terms

Code	Name	Definition	Implantable	Status
18135	Gastrointestinal anastomosis coupler, non-bioabsorbable	An implantable device intended to be used to join and transect excess tissue of gastrointestinal structures through the coupling of two ring-shaped components that are inserted into the ends of the segments to be attached. This device is made of a substance or material that cannot be chemically degraded or absorbed via natural body processes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10827002472836	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dark, dry, cool place.