iDuo® Patella Sizer

GUDID 00850268007415

iDuo® 35mm Patella Sizer Reusable Instrument

Conformis, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00850268007415
• NIH Device Record Key: 06af0a44-05e9-454d-b56e-1b0f26a337b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iDuo® Patella Sizer
• Version Model Number: 1080-408
• Company DUNS: 808821883
• Company Name: Conformis, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com
• Phone: 781-345-9001
• Email: customer-service@conformis.com

Device Dimensions

• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850268007415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133256

FDA Product Code

• NPJ: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

[00850268007415]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-24

On-Brand Devices [iDuo® Patella Sizer]

• 00850268007439: iDuo® 41mm Patella Sizer Reusable Instrument
• 00850268007422: iDuo® 38mm Patella Sizer Reusable Instrument
• 00850268007415: iDuo® 35mm Patella Sizer Reusable Instrument