Endofix EXO

GUDID 04260463849431

Aktormed GmbH

Surgical camera holder

• Primary Device ID: 04260463849431
• NIH Device Record Key: f2da40fd-2fef-4cca-bb4d-97c8346f7321
• Commercial Distribution Discontinuation: 2025-07-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Endofix EXO
• Version Model Number: 171943
• Company DUNS: 537223815
• Company Name: Aktormed GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260463849431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232405

FDA Product Code

• OCV: Endoscope Holder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by Aktormed GmbH

• 04260463849431 - Endofix EXO: 2025-08-07
• 04260463849431 - Endofix EXO: 2025-08-07
• 04260463845181 - PROBE PIN: 2024-10-10 autoclavable accessories for the DEXTER ENDOSCOPE ARM
• 04260463842821 - STERILISATION TRAY XL: 2024-10-09 autoclavable accessories for the DEXTER ENDOSCOPE ARM
• 04260463844801 - CANTILEVER: 2024-10-09 autoclavable accessories for the DEXTER ENDOSCOPE ARM
• 04260463844825 - JOINT: 2024-10-09 autoclavable accessories for the DEXTER ENDOSCOPE ARM
• 04260463844993 - Dexter Endoscope Arm: 2024-10-09 customized SOLOASSIST II for Dexter, incl. Power supply and supply cable
• 04260463845907 - ENDOSCOPE CLAMP: 2024-10-09 autoclavable accessories for the DEXTER ENDOSCOPE ARM
• 04260463840964 - STERILE COVER PU /10 EA.: 2022-04-20 10x AKTORMED PROBE COVER 30cm X 178cm (00748426105830)