MectaTap

GUDID 07630040734233

MectaTap TI Ø6.5

Medacta International SA

Soft-tissue/mesh anchor, non-bioabsorbable

• Primary Device ID: 07630040734233
• NIH Device Record Key: eb48db43-cefc-4847-b0c1-6ae721c21c20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MectaTap
• Version Model Number: 05.10.014
• 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	07630040734233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191677

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2020-02-03

On-Brand Devices [MectaTap]

• 07630040734233: MectaTap TI Ø6.5
• 07630040734226: MectaTap TI Ø5.0