Bipolar Heads

GUDID 07630030843716

Ø28x50

Medacta International SA

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• Primary Device ID: 07630030843716
• NIH Device Record Key: 8d998155-18f9-4582-b8c3-4850826317dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar Heads
• Version Model Number: 25060.2850
• Company DUNS: 488227125
• Company Name: Medacta International SA
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630030843716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091967

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-11-18

On-Brand Devices [Bipolar Heads]

• 07630030843914: Ø28x60
• 07630030843891: Ø28x59
• 07630030843877: Ø28x58
• 07630030843853: Ø28x57
• 07630030843839: Ø28x56
• 07630030843815: Ø28x55
• 07630030843792: Ø28x54
• 07630030843778: Ø28x53
• 07630030843754: Ø28x52
• 07630030843730: Ø28x51
• 07630030843716: Ø28x50
• 07630030843693: Ø28x49
• 07630030843679: Ø28x48
• 07630030843655: Ø28x47
• 07630030843631: Ø28x46
• 07630030843617: Ø28x45
• 07630030843594: Ø28x44
• 07630030843532: Ø22x52
• 07630030843518: Ø22x51
• 07630030843495: Ø22x50
• 07630030843471: Ø22x49
• 07630030843457: Ø22x48
• 07630030843433: Ø22x47
• 07630030843419: Ø22x46
• 07630030843396: Ø22x45
• 07630030843372: Ø22x44
• 07630030843358: Ø22x43
• 07630030843334: Ø22x42
• 07630030843310: Ø22x41
• 07630030843297: Ø22x40