MIS 4MATRIX

GUDID 07290108992533

4MATRIX Bone Graft Cement professional sample

MIS Implants Technologies Ltd.

Synthetic bone graft

• Primary Device ID: 07290108992533
• NIH Device Record Key: 4daabf8b-add8-42f5-b1c5-52a20ed0c4b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS 4MATRIX
• Version Model Number: BS-4MXSP
• Company DUNS: 514576057
• Company Name: MIS Implants Technologies Ltd.
• 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: true
• 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	07290108992533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121177

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [MIS 4MATRIX]

• 07290108992533: 4MATRIX Bone Graft Cement professional sample
• 07290108992526: 4MATRIX Bone Graft Cement 1cc