Uni FB PE-insert

GUDID 04048844030148

implantcast GmbH

Unicondylar knee insert

• Primary Device ID: 04048844030148
• NIH Device Record Key: d8dc3835-c7fd-4cd1-ac0f-39864f055352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni FB PE-insert
• Version Model Number: 40100210
• 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

• 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	04048844030148 [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 PE-insert]

• 04048844480240: 40100414
• 04048844480233: 40100412
• 04048844480226: 40100314
• 04048844480219: 40100312
• 04048844480202: 40100214
• 04048844480196: 40100212
• 04048844480189: 40100114
• 04048844480172: 40100112
• 04048844480165: 40101014
• 04048844480158: 40101012
• 04048844480141: 40101011
• 04048844480134: 40101010
• 04048844480127: 40101009
• 04048844480110: 40101008
• 04048844030230: 40100411
• 04048844030223: 40100410
• 04048844030216: 40100409
• 04048844030209: 40100408
• 04048844030193: 40100311
• 04048844030186: 40100310
• 04048844030179: 40100309
• 04048844030162: 40100308
• 04048844030155: 40100211
• 04048844030148: 40100210
• 04048844030131: 40100209
• 04048844030124: 40100208
• 04048844030117: 40100111
• 04048844030100: 40100110
• 04048844030094: 40100109
• 04048844030087: 40100108