iTotal® CR iPoly™ Insert Kit RCR0101600

GUDID M572RCR0101600021

Conformis, Inc.

Total knee prosthesis implantation guide-instrument kit
Primary Device IDM572RCR0101600021
NIH Device Record Keyc3f7dd49-383d-4abf-a5b6-5ff490856c1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® CR iPoly™ Insert Kit
Version Model NumberRCR010160002
Catalog NumberRCR0101600
Company DUNS808821883
Company NameConformis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com
Phone781-345-9001
Emailcustomer-service@conformis.com

Device Dimensions

Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter
Height16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM572RCR0101600021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-08-15
Device Publish Date2015-10-26

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

M572RCR0101200011N/A
M572RCR010000E031N/A
M572RCR0101600021RCR010160002
M572RCR0100800021ITOTAL CR?IPOLY?8MM MEDIAL INSERT KIT?LEFT
M572RCR010000K011N/A
M572RCR010000J011N/A
M572RCR010000I011N/A
M572RCR010000D031N/A
M572RCR0100700011N/A

Trademark Results [iTotal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ITOTAL
ITOTAL
79337466 not registered Live/Pending
TOTAL JUGGLING S.r.l
2021-10-06
ITOTAL
ITOTAL
77519937 4006512 Live/Registered
ConforMIS, Inc.
2008-07-11
ITOTAL
ITOTAL
77200561 not registered Dead/Abandoned
ConforMIS, Inc.
2007-06-07
ITOTAL
ITOTAL
76133213 2498210 Dead/Cancelled
ConnecTotal Staffing, Inc.
2000-09-22

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