My Knee Tibial Cutting Blocks

GUDID 07630030848186

CT Left Medial #3 Sterile

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use

• Primary Device ID: 07630030848186
• NIH Device Record Key: 18d86bc9-b84d-4ebe-9c12-f8602ed5e88e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: My Knee Tibial Cutting Blocks
• Version Model Number: 4.1033S
• 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	07630030848186 [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 Tibial Cutting Blocks]

• 07630030852480: MRI Right Lateral #6 Sterile
• 07630030852473: MRI Right Lateral #6
• 07630030852466: MRI Right Lateral #5 Sterile
• 07630030852459: MRI Right Lateral #5
• 07630030852442: MRI Right Lateral #4 Sterile
• 07630030852435: MRI Right Lateral #4
• 07630030852428: MRI Right Lateral #3 Sterile
• 07630030852411: MRI Right Lateral #3
• 07630030852404: MRI Right Lateral #2 Sterile
• 07630030852398: MRI Right Lateral #2
• 07630030852381: MRI Right Lateral #1 Sterile
• 07630030852374: MRI Right Lateral #1
• 07630030852367: MRI Left Lateral #6 Sterile
• 07630030852350: MRI Left Lateral #6
• 07630030852343: MRI Left Lateral #5 Sterile
• 07630030852336: MRI Left Lateral #5
• 07630030852329: MRI Left Lateral #4 Sterile
• 07630030852312: MRI Left Lateral #4
• 07630030852305: MRI Left Lateral #3 Sterile
• 07630030852299: MRI Left Lateral #3
• 07630030852282: MRI Left Lateral #2 Sterile
• 07630030852275: MRI Left Lateral #2
• 07630030852268: MRI Left Lateral #1 Sterile
• 07630030852251: MRI Left Lateral #1
• 07630030851964: MRI Right Medial #6 Sterile
• 07630030851957: MRI Right Medial #6
• 07630030851940: MRI Right Medial #5 Sterile
• 07630030851933: MRI Right Medial #5
• 07630030851926: MRI Right Medial #4 Sterile
• 07630030851919: MRI Right Medial #4
• 07630030851902: MRI Right Medial #3 Sterile
• 07630030851896: MRI Right Medial #3
• 07630030851889: MRI Right Medial #2 Sterile
• 07630030851872: MRI Right Medial #2
• 07630030851865: MRI Right Medial #1 Sterile
• 07630030851858: MRI Right Medial #1
• 07630030851841: MRI Left Medial #6 Sterile
• 07630030851834: MRI Left Medial #6
• 07630030851827: MRI Left Medial #5 Sterile
• 07630030851810: MRI Left Medial #5
• 07630030851803: MRI Left Medial #4 Sterile
• 07630030851797: MRI Left Medial #4
• 07630030851780: MRI Left Medial #3 Sterile
• 07630030851773: MRI Left Medial #3
• 07630030851766: MRI Left Medial #2 Sterile
• 07630030851759: MRI Left Medial #2
• 07630030851742: MRI Left Medial #1 Sterile
• 07630030851735: MRI Left Medial #1
• 07630030848889: CT Right Lateral #6 Sterile
• 07630030848872: CT Right Lateral #6