ArchiMIS AD-1ch-4.0-120

GUDID 00857373006111

Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system)

AVITUS ORTHOPAEDICS, INC.

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• Primary Device ID: 00857373006111
• NIH Device Record Key: 35223f38-11a9-4ff5-a0d8-e2d056967c5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ArchiMIS
• Version Model Number: AD-1ch-4.0-120
• Catalog Number: AD-1ch-4.0-120
• Company DUNS: 078269403
• Company Name: AVITUS ORTHOPAEDICS, INC.
• 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

Customer Support Contacts

• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com
• Phone: 8606379922
• Email: neil@avitusortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857373006111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230492

FDA Product Code

• FMF: Syringe, Piston

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: 2023-07-27
• Device Publish Date: 2023-07-19

Devices Manufactured by AVITUS ORTHOPAEDICS, INC.

• 00857373006128 - DragonWing: 2023-09-05 Avitus DragonWing Large Volume Autograft Delivery (Ø5.2mm, 120mm system)
• 00857373006111 - ArchiMIS: 2023-07-27Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system)
• 00857373006111 - ArchiMIS: 2023-07-27 Avitus® ArchiMIS Precision Autograft Delivery (Ø4.0mm, 120mm system)
• 00857373006074 - Avitus Bone Harvester: 2020-10-16 Sterile, disposable surgical instrument with 6mm cutting tip for large volume, cancellous bone and marrow harvesting with marrow
• 00857373006005 - Avitus Bone Harvester: 2018-07-06 A manual surgical instrument that cuts cancellous bone by manual actuation of the 8mm cutting tip. The cap contains a barbed noz
• 00857373006029 - Avitus Bone Harvester: 2018-07-06 Filter Accessory for REF: BH8 ONLY
• 00857373006050 - Avitus Bone Harvester: 2018-07-06 A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting tip. The cap contains a barbed noz
• 00857373006036 - Avitus Bone Harvester: 2018-03-29 A manual surgical instrument that cuts cancellous bone by manual actuation of the 5mm cutting tip. The cap contains a barbed noz