iDuo® Patella Trial

GUDID 00850268007392

iDuo® 41mm Patella Trial Reusable Instrument

Conformis, Inc.

Patella prosthesis trial
Primary Device ID00850268007392
NIH Device Record Key512e8ec9-2c8f-44b6-bb68-e65a6e4bc704
Commercial Distribution StatusIn Commercial Distribution
Brand NameiDuo® Patella Trial
Version Model Number1080-405
Company DUNS808821883
Company NameConformis, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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

Device Dimensions

Outer Diameter41 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850268007392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NPJProsthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850268007392]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-10-24

On-Brand Devices [iDuo® Patella Trial ]

00850268007392iDuo® 41mm Patella Trial Reusable Instrument
00850268007385iDuo® 38mm Patella Trial Reusable Instrument
00850268007378iDuo® 35mm Patella Trial Reusable Instrument
00850268007361iDuo® 32mm Patella Trial Reusable Instrument

Trademark Results [iDuo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IDUO
IDUO
85794905 not registered Dead/Abandoned
i do it sarl
2012-12-05
IDUO
IDUO
85518103 4270942 Live/Registered
Liang, Hsien-Rong
2012-01-17
IDUO
IDUO
78652189 not registered Dead/Abandoned
Liang, Hsien-Rong
2005-06-16
IDUO
IDUO
77200574 3459154 Dead/Cancelled
ConforMIS, Inc.
2007-06-07
IDUO
IDUO
77087559 not registered Dead/Abandoned
I DO IT SPRLU
2007-01-22

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