MonoBalloon URO

Basic Information

• Brand Name: MonoBalloon URO
• Primary DI: 04048223078280
• Version / Model: 1284-70-11S
• Catalog Number: 1284-70-11S
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-25
• Public Version: 2
• Public Version Date: 2025-12-01
• Public Version Status: Update
• Public Device Record Key: 8db210e2-df51-4300-bdc0-530e82b55df5

Device Description

MonoBalloon URO URO ring-anchor 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
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
Package	04048223057704	GS1		5	In Commercial Distribution
Primary	04048223078280	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090631	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	11.0	Millimeter

Storage Conditions

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