Uni FB tibial component LL/RM

GUDID 04048844205348

implantcast GmbH

Uncoated unicondylar knee tibia prosthesis, metallic

• Primary Device ID: 04048844205348
• NIH Device Record Key: c77d59c1-92f1-4369-977c-826c96e956db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni FB tibial component LL/RM
• Version Model Number: 40100013
• Company DUNS: 324369826
• Company Name: implantcast 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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 Dimensions

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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844205348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203341

FDA Product Code

• HSX: Prosthesis, Knee, Femorotibial, Non-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: 2021-01-20
• Device Publish Date: 2021-01-12

On-Brand Devices [Uni FB tibial component LL/RM]

• 04048844480103: 40100017
• 04048844480097: 40100016
• 04048844480080: 40100010
• 04048844205355: 40100014
• 04048844205348: 40100013
• 04048844205331: 40100012
• 04048844205324: 40100011