iUni® iPoly™ Insert Kit RUK0101000

GUDID M572RUK0101000011

N/A

Conformis, Inc.

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• Primary Device ID: M572RUK0101000011
• NIH Device Record Key: 25bac459-b56a-4db7-8503-5faf7022f78e
• Commercial Distribution Discontinuation: 2022-08-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iUni® iPoly™ Insert Kit
• Version Model Number: RUK010100001
• Catalog Number: RUK0101000
• 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: 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
• 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: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M572RUK0101000011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072586

FDA Product Code

• OOG: Knee Arthroplasty Implantation System

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: 2022-08-16
• Device Publish Date: 2015-10-26

On-Brand Devices [iUni® iPoly™ Insert Kit]

• M572RUK0101400011: N/A
• M572RUK0101300011: N/A
• M572RUK0101200011: N/A
• M572RUK0101100011: N/A
• M572RUK0101000011: N/A
• M572RUK0100900011: N/A
• M572RUK0100800011: N/A
• M572RUK0100700011: N/A
• M572RUK0100600011: N/A