Episealer Knee Revision Guide 18100PF

GUDID EPIS18100PF0

Episurf Operations AB

Joint prosthesis implantation kit, single-use

• Primary Device ID: EPIS18100PF0
• NIH Device Record Key: f8a68eb5-56f7-4c50-95d5-2149e5419632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Episealer Knee Revision Guide
• Version Model Number: First version
• Catalog Number: 18100PF
• Company DUNS: 352393402
• Company Name: Episurf Operations AB
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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
HIBCC	EPIS18100PF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221048

FDA Product Code

• KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

Devices Manufactured by Episurf Operations AB

• EPIS18100PF0 - Episealer Knee Revision Guide: 2023-08-01
• 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
• EPIS33120PF0 - Femoral Drilling Socket: 2023-08-01