Coloplast

Basic Information

• Brand Name: Coloplast
• Primary DI: 05708932752558
• Version / Model: 12814
• Catalog Number: 12814
• Company Name: Coloplast A/S
• Labeler DUNS: 305524696
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-26
• Public Version: 1
• Public Version Date: 2023-01-03
• Public Version Status: New
• Public Device Record Key: 6b59cde1-2ffe-432e-ad4f-396a4a306dd8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EZP	Rod, colostomy	Gastroenterology, Urology	876.4270	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31987	Colostomy rod	A device that is placed through a loop of colon brought out through the abdominal wall to temporarily keep it from sliping back through the surgical opening during the loop colostomy procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05708932651349	GS1	Retail Box	10	In Commercial Distribution
Primary	05708932752558	GS1
Package	05708932651356	GS1	Shipper Box	16	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged and consult IFU.