MectaPlug PE II

GUDID 07630345710994

MectaPlug PE II size XL

Medacta International SA

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 07630345710994
• NIH Device Record Key: 8a0c742a-d3a8-4e57-8c8b-55abc3a3ef85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaPlug PE II
• Version Model Number: 01.33.204
• 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	07630345710994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210062

FDA Product Code

• JDK: Prosthesis, Hip, Cement Restrictor

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: 2021-04-26
• Device Publish Date: 2021-04-16

On-Brand Devices [MectaPlug PE II]

• 07630345711007: MectaPlug PE II size XXL
• 07630345710994: MectaPlug PE II size XL
• 07630345710987: MectaPlug PE II size L
• 07630345710970: MectaPlug PE II size M
• 07630345710963: MectaPlug PE II size S