BLUEENDO

Basic Information

• Brand Name: BLUEENDO
• Primary DI: 04251303811381
• Version / Model: 02-33106
• Catalog Number: 02-33106
• Company Name: TROKAMED GmbH
• Labeler DUNS: 341943858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-11
• Public Version: 1
• Public Version Date: 2021-05-19
• Public Version Status: New
• Public Device Record Key: 95058d65-dea9-44f4-8b5a-4566e84c623c

Device Description

Obturator Ø 15 mm, to be used with 02-33103, Color Code grey

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251303811381	GS1

Customer Contacts

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