Femoral Epidummy 34120PF

GUDID EPIS34120PF0

Episurf Operations AB

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• Primary Device ID: EPIS34120PF0
• NIH Device Record Key: 6069d8cb-f2c0-47be-8fe4-0612c7f498d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral Epidummy
• Version Model Number: D20
• Catalog Number: 34120PF
• 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	EPIS34120PF0 [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

On-Brand Devices [Femoral Epidummy]

• EPIS54125PF0: 2xD25
• EPIS54120PF0: 2xD20
• EPIS54117PF0: 2xD17
• EPIS34129PF0: D29
• EPIS34125PF0: D25
• EPIS34120PF0: D20