My Knee Femoral Cutting Blocks

GUDID 07630030848384

CT Left Lateral #1 Sterile

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030848384
• NIH Device Record Key: 88e36590-105e-452e-8833-5b0dbc275b12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Knee Femoral Cutting Blocks
• Version Model Number: 4.1061S
• 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	07630030848384 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093806

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2014-11-18

On-Brand Devices [My Knee Femoral Cutting Blocks]

• 07630030852244: MRI Right Lateral #7 Sterile
• 07630030852237: MRI Right Lateral #7
• 07630030852220: MRI Right Lateral #6 Sterile
• 07630030852213: MRI Right Lateral #6
• 07630030852206: MRI Right Lateral #5 Sterile
• 07630030852190: MRI Right Lateral #5
• 07630030852183: MRI Right Lateral #4 Sterile
• 07630030852176: MRI Right Lateral #4
• 07630030852169: MRI Right Lateral #3 Sterile
• 07630030852152: MRI Right Lateral #3
• 07630030852145: MRI Right Lateral #2 Sterile
• 07630030852138: MRI Right Lateral #2
• 07630030852121: MRI Right Lateral #1 Sterile
• 07630030852114: MRI Right Lateral #1
• 07630030852107: MRI Left Lateral #7 Sterile
• 07630030852091: MRI Left Lateral #7
• 07630030852084: MRI Left Lateral #6 Sterile
• 07630030852077: MRI Left Lateral #6
• 07630030852060: MRI Left Lateral #5 Sterile
• 07630030852053: MRI Left Lateral #5
• 07630030852046: MRI Left Lateral #4 Sterile
• 07630030852039: MRI Left Lateral #4
• 07630030852022: MRI Left Lateral #3 Sterile
• 07630030852015: MRI Left Lateral #3
• 07630030852008: MRI Left Lateral #2 Sterile
• 07630030851995: MRI Left Lateral #2
• 07630030851988: MRI Left Lateral #1 Sterile
• 07630030851971: MRI Left Lateral #1
• 07630030851728: MRI Right Medial #7 Sterile
• 07630030851711: MRI Right Medial #7
• 07630030851704: MRI Right Medial #6 Sterile
• 07630030851698: MRI Right Medial #6
• 07630030851681: MRI Right Medial #5 Sterile
• 07630030851674: MRI Right Medial #5
• 07630030851667: MRI Right Medial #4 Sterile
• 07630030851650: MRI Right Medial #4
• 07630030851643: MRI Right Medial #3 Sterile
• 07630030851636: MRI Right Medial #3
• 07630030851629: MRI Right Medial #2 Sterile
• 07630030851612: MRI Right Medial #2
• 07630030851605: MRI Right Medial #1 Sterile
• 07630030851599: MRI Right Medial #1
• 07630030851582: MRI Left Medial #7 Sterile
• 07630030851575: MRI Left Medial #7
• 07630030851568: MRI Left Medial #6 Sterile
• 07630030851551: MRI Left Medial #6
• 07630030851544: MRI Left Medial #5 Sterile
• 07630030851537: MRI Left Medial #5
• 07630030851520: MRI Left Medial #4 Sterile
• 07630030851513: MRI Left Medial #4