MISHA(TM) Knee System, Large, Left 2-1003

GUDID 00856047005818

Moximed, Inc.

Implantable knee unloader

• Primary Device ID: 00856047005818
• NIH Device Record Key: 7ba9d9e9-e2ee-493f-8bd5-5785cf2e91b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MISHA(TM) Knee System, Large, Left
• Version Model Number: 102741
• Catalog Number: 2-1003
• Company DUNS: 808178383
• Company Name: Moximed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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	00856047005818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220033

FDA Product Code

• QVV: Medial Knee Implanted Shock Absorber

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: 2023-05-15
• Device Publish Date: 2023-05-05

Devices Manufactured by Moximed, Inc.

• 00856047005795 - MISHA(TM) Knee System, Small, Left: 2023-05-15
• 00856047005801 - MISHA(TM) Knee System, Small, Right: 2023-05-15
• 00856047005818 - MISHA(TM) Knee System, Large, Left: 2023-05-15
• 00856047005818 - MISHA(TM) Knee System, Large, Left: 2023-05-15
• 00856047005825 - MISHA(TM) Knee System, Large, Right: 2023-05-15
• 00856047005832 - MISHA(TM) Locking Screw, 5.0 x 46 mm, 6-Pack: 2023-05-15
• 00856047005849 - MISHA(TM) Locking Screw, 5.0 x 46 mm, 1-Pack: 2023-05-15
• 00856047005856 - MISHA(TM) Trial, Small, Left: 2023-05-15
• 00856047005863 - MISHA(TM) Trial, Small, Right: 2023-05-15