restor3d Kinos Axiom Instrumentation

GUDID 00840097507484

Talar Peg Drill, Non-Sterile

Restor3d

Joint prosthesis implantation kit, single-use

• Primary Device ID: 00840097507484
• NIH Device Record Key: c6b88440-e573-406f-9c0b-afef0b013b61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: restor3d Kinos Axiom Instrumentation
• Version Model Number: 5801-0045
• Company DUNS: 080819836
• Company Name: Restor3d
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840097507484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192778

FDA Product Code

• HSN: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

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

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

[00840097507484]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [restor3d Kinos Axiom Instrumentation]

• 00840097507484: Talar Peg Drill, Non-Sterile
• 00840097509341: Chamfer Kit, Sterile