PB Uni tibial trial component

GUDID 04048844205317

implantcast GmbH

Knee tibia prosthesis trial

• Primary Device ID: 04048844205317
• NIH Device Record Key: 666b6d89-603e-41e3-8aec-9791b38559fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PB Uni tibial trial component
• Version Model Number: 40120024
• 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: false
• Lot Batch: true
• 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 Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844205317 [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: true
• Device Is Sterile: false

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

[04048844205317]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-25
• Device Publish Date: 2021-01-15

On-Brand Devices [PB Uni tibial trial component]

• 04048844541439: 40120016
• 04048844541422: 40120015
• 04048844541415: 40120010
• 04048844541408: 40120026
• 04048844541392: 40120025
• 04048844541385: 40120020
• 04048844205317: 40120024
• 04048844205300: 40120023
• 04048844205294: 40120022
• 04048844205287: 40120021
• 04048844205270: 40120014
• 04048844205263: 40120013
• 04048844205256: 40120012
• 04048844205249: 40120011