X-PSI™ 20-8017-035-00

GUDID 00889024486751

Orthosoft Inc

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID00889024486751
NIH Device Record Keyfa1da233-4298-465a-a8f7-691b3f03b31d
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-PSI™
Version Model Number20-8017-035-00
Catalog Number20-8017-035-00
Company DUNS205670032
Company NameOrthosoft 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

Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com
Phone1(800)348-2759
Emailzimmer.consumerrelations@zimmer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100889024486751 [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

[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


[00889024486751]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2018-04-18

On-Brand Devices [X-PSI™]

0088902448678220-8017-038-00
0088902448677520-8017-037-00
0088902448676820-8017-036-00
0088902448675120-8017-035-00
0088902448674420-8017-034-00
0088902448673720-8017-033-00
0088902448672020-8017-032-00
0088902448671320-8017-031-00
0088902448670620-8017-030-00
0088902448663820-8085-020-00

Trademark Results [X-PSI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-PSI
X-PSI
73541338 1405494 Dead/Cancelled
XALOY INCORPORATED
1985-06-05

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