iTotal® CR iPoly™ Insert Kit RCR0101600

GUDID M572RCR0101600021

Conformis, Inc.

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• Primary Device ID: M572RCR0101600021
• NIH Device Record Key: c3f7dd49-383d-4abf-a5b6-5ff490856c1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTotal® CR iPoly™ Insert Kit
• Version Model Number: RCR010160002
• Catalog Number: RCR0101600
• Company DUNS: 808821883
• Company Name: Conformis, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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

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

Device Dimensions

• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter
• Height: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RCR0101600021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120316

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-08-15
• Device Publish Date: 2015-10-26

On-Brand Devices [iTotal® CR iPoly™ Insert Kit]

• M572RCR0101200011: N/A
• M572RCR010000E031: N/A
• M572RCR0101600021: RCR010160002
• M572RCR0100800021: ITOTAL CR?IPOLY?8MM MEDIAL INSERT KIT?LEFT
• M572RCR010000K011: N/A
• M572RCR010000J011: N/A
• M572RCR010000I011: N/A
• M572RCR010000D031: N/A
• M572RCR0100700011: N/A