PB Uni tibial trial insert

GUDID 04048844030995

implantcast GmbH

Knee tibia prosthesis trial

• Primary Device ID: 04048844030995
• NIH Device Record Key: c3bfee99-1f1e-49d8-bbb6-49dc99baa28a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PB Uni tibial trial insert
• Version Model Number: 40120210
• 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	04048844030995 [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

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

Moist Heat or Steam Sterilization

[04048844030995]

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 insert]

• 04048844504267: 40120412
• 04048844504250: 40120312
• 04048844504243: 40120212
• 04048844504236: 40120112
• 04048844503499: 40120414
• 04048844503482: 40120314
• 04048844503475: 40120214
• 04048844503468: 40120114
• 04048844503451: 40120914
• 04048844503437: 40120912
• 04048844503420: 40120911
• 04048844503413: 40120910
• 04048844503406: 40120909
• 04048844503376: 40120908
• 04048844031084: 40120411
• 04048844031077: 40120410
• 04048844031060: 40120409
• 04048844031053: 40120408
• 04048844031046: 40120311
• 04048844031039: 40120310
• 04048844031022: 40120309
• 04048844031015: 40120308
• 04048844031008: 40120211
• 04048844030995: 40120210
• 04048844030988: 40120209
• 04048844030971: 40120208
• 04048844030964: 40120111
• 04048844030957: 40120110
• 04048844030940: 40120109
• 04048844030933: 40120108