EcoBalloon DIL-BI

Basic Information

• Brand Name: EcoBalloon DIL-BI
• Primary DI: 04048223133033
• Version / Model: 1285-50-11
• Catalog Number: 1285-50-11
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-17
• Public Version: 2
• Public Version Date: 2025-06-26
• Public Version Status: Update
• Public Device Record Key: 8eb218d4-fb1c-4da5-b3b4-031b593b96e7

Device Description

EcoBalloon DIL-BI Bilateral dilatation balloon Ø 11mm for extraperitoneal surgery

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: Yes
• 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
44794	Surgical balloon dissector	A device used to dissect connective tissue layers creating access to a surgical site for a variety of surgical procedures. The device typically consists of a cannula, a distention balloon, an obturator, an inflation bulb, and a regulating valve(s). An endoscope is introduced into the cannula to monitor the dissection and/or the insertion process. The balloon is inflated to fill volume exerting pressure on the tissue layers. It is then deflated and removed, and distention is maintained by infusion of carbon dioxide (CO2) via the cannula. This device can be used for hernia repair, varicocele dissection, sympathectomy, lymph node biopsy, or perforator vein ligation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04048223133293	GS1		5	In Commercial Distribution
Primary	04048223133033	GS1
Previous	04048223057971	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090631	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 20 – 65 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius