ESTEEM SYNERGY

Basic Information

• Brand Name: ESTEEM SYNERGY
• Primary DI: 00768455104772
• Version / Model: 405406
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-02-08
• Public Version: 3
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: c33518ed-96b6-4ed2-a0bd-2e3f2a3c564e
• Distribution End Date: 2022-05-20

Device Description

Esteem Synergy, 14 in., Drainable Pouch with 1 Sided Comfort Panel, Transparent, Straight, Extra-Large

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: 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
31066	One-piece intestinal ostomy bag, closed-ended	A plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10768455104779	GS1	Case	24	Not in Commercial Distribution	2022-05-20
Primary	00768455104772	GS1
Unit of Use	80768455104778	GS1

Customer Contacts

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