EpisurfView

GUDID EPIS960010

Episurf Operations AB

Radiology DICOM image processing application software

• Primary Device ID: EPIS960010
• NIH Device Record Key: b2edeb23-39c5-4da0-9b9c-3411eed8f597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpisurfView
• Version Model Number: 1.0
• Company DUNS: 352393402
• Company Name: Episurf Operations AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPIS960010 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

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: 2026-03-25
• Device Publish Date: 2026-03-17

Devices Manufactured by Episurf Operations AB

• EPIS960010 - EpisurfView: 2026-03-25
• EPIS960010 - EpisurfView: 2026-03-25
• EPIS18100PF0 - Episealer Knee Revision Guide: 2023-08-01
• EPIS31120PF0 - Femoral Component: 2023-08-01
• EPIS31125PF0 - Femoral Component: 2023-08-01
• EPIS31129PF0 - Femoral Component: 2023-08-01
• EPIS32120PF0 - Femoral Epidrill: 2023-08-01
• EPIS32125PF0 - Femoral Epidrill: 2023-08-01
• EPIS32129PF0 - Femoral Epidrill: 2023-08-01