iTotal® Poly Impactor Tip

GUDID 00850268007453

iTotal® Poly Impactor Tip Reusable Instrument

Conformis, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00850268007453
NIH Device Record Key7bc6f1ec-1342-46ae-8f7a-bb9bb8a460ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameiTotal® Poly Impactor Tip
Version Model Number1080-549
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
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
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850268007453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


[00850268007453]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-06
Device Publish Date2018-08-06

On-Brand Devices [iTotal® Poly Impactor Tip]

00850268007453iTotal® Poly Impactor Tip Reusable Instrument
00850268007224iTotal® Poly Impactor Tip Reusable Instrument

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.