SUR-FIT LOOP OSTOMY ROD 65MM

Basic Information

• Brand Name: SUR-FIT LOOP OSTOMY ROD 65MM
• Primary DI: 00768455115501
• Version / Model: 022355
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 9
• Public Version Date: 2023-04-24
• Public Version Status: Update
• Public Device Record Key: 7161a81b-5ebc-4b4e-985e-bf2c7b5dd748

Device Description

ConvaTec Loop Ost Rod 65Mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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	10768455115508	GS1	Case	12	In Commercial Distribution
Primary	00768455115501	GS1
Unit of Use	00768455179015	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.5	Centimeter