blueendo

Basic Information

• Brand Name: blueendo
• Primary DI: 04251303822264
• Version / Model: 02-00091
• Catalog Number: 02-00091
• Company Name: TROKAMED GmbH
• Labeler DUNS: 341943858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-04
• Public Version: 1
• Public Version Date: 2025-04-14
• Public Version Status: New
• Public Device Record Key: 7072be42-bc44-4b02-b300-cd5ff3207067

Device Description

My Tube-colpotomy-set consisting of basic tube, cap Ø 40mm, Ø cap 50mm, one packaging unit sealing valve, sterile, single use

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
15677	Uterine elevator	A hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251303822264	GS1

Customer Contacts

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