EcoBalloonDuo DIL-BI + URO

Basic Information

• Brand Name: EcoBalloonDuo DIL-BI + URO
• Primary DI: 14048223020941
• Version / Model: 1285-50-28S
• Catalog Number: 1285-50-28S
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-04-16
• Public Version: 2
• Public Version Date: 2021-03-16
• Public Version Status: Update
• Public Device Record Key: 8eec02a4-9227-4391-8b33-d41021d53601
• Distribution End Date: 2025-03-15

Device Description

EcoBalloonDuo DIL-BI + URO Bilateral double balloon set Ø 11mm for extraperitoneal surgery,

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: Yes
• 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
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45342	Laparoscopic access cannula anchor, single-use	A small, sterile, luminal device designed to enable a laparoscopic access cannula (port) to be secured to the skin/tissue of an incision site during a laparoscopic surgical procedure. The outer surface is typically textured/ribbed and intended to grip the tissue whilst the laparoscopic access cannula is inserted through the device lumen and fixed at the required insertion depth using a clamping/locking mechanism. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14048223020941	GS1
Unit of Use	04048223020944	GS1

Customer Contacts

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