ENDOFIX EXO SET

Basic Information

• Brand Name: ENDOFIX EXO SET
• Primary DI: 04260463849127
• Version / Model: 171912
• Company Name: Aktormed GmbH
• Labeler DUNS: 537223815
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-25
• Public Version: 2
• Public Version Date: 2026-03-19
• Public Version Status: Update
• Public Device Record Key: 025bfa80-204a-4d7f-9d1b-46d0e910bf9a

Device Description

with quick fastener to OR table Supply: 100 - 240 V, 50 - 60 Hz, 2,5 A consisting of: 1x arm system for endoscopes/exoscopes with 6 lockable axis (including power supply, power cord and supply cable) 1x trolley

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCV	Endoscope Holder	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32288	Surgical camera holder	A non-powered device designed to hold or stabilize a video camera or endoscope (e.g., to a table or rail) while recording a surgical operative procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260463849127	GS1

Premarket Submissions

Submission Number	Supplement Number
K232405	000