ESTEEM SYNERGY+

Basic Information

• Brand Name: ESTEEM SYNERGY+
• Primary DI: 00768455114658
• Version / Model: 416779
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2022-10-14
• Public Version: 1
• Public Version Date: 2022-10-24
• Public Version Status: New
• Public Device Record Key: 30fff983-242d-4320-91e0-7f0b707c964b

Device Description

ESTEEM SYN+ PCH CLDWFSTDTAN 48MM(1X30)US

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EZQ	POUCH, COLOSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31067	Multiple-piece intestinal ostomy bag, closed-ended	A plastic pouch designed to be attached around a faecal stoma for use as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The base plate remains attached around the stoma, typically for 2 to 3 days, when the pouch is removed and replaced. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455114655	GS1		6	In Commercial Distribution
Primary	00768455114658	GS1
Unit of Use	00768455188666	GS1

Customer Contacts

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