Journey II E0016054-5

GUDID 00885556726068

DOUBLE ENDED STYLUS - 2MM / 9MM

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00885556726068
NIH Device Record Keycf75bffe-0c9d-40fc-807e-1267cbac036e
Commercial Distribution StatusIn Commercial Distribution
Brand NameJourney II
Version Model NumberE0016054-5
Catalog NumberE0016054-5
Company DUNS109903521
Company NameSmith & Nephew, 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

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556726068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSXPROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


[00885556726068]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-14
Device Publish Date2018-08-14

On-Brand Devices [Journey II]

00885556741665TIBIAL BLOCK - RIGHT
00885556741658TIBIAL BLOCK - LEFT
00885556741375TIBIAL STEM STEP REAMER - 14MM
008855567413682MM RECUT BLOCK
00885556740453ANKLE CLAMP
00885556740446MICRO ALIGNMENT GUIDE
00885556740439MACRO ALIGNMENT GUIDE
008855567398082MM TIBIAL BLOCK SHIM - RIGHT
008855567397782MM TIBIAL BLOCK SHIM - LEFT
008855567396792MM RECUT BLOCK
00885556739372MEDIAL PLUS FIN PUNCH - SZ 7-8 R
00885556739365MEDIAL PLUS FIN PUNCH - SZ 7-8 L
00885556739358MEDIAL PLUS FIN PUNCH - SZ 5-6 R
00885556739341MEDIAL PLUS FIN PUNCH - SZ 5-6 L
00885556739334MEDIAL PLUS FIN PUNCH - SZ 3-4 R
00885556739327MEDIAL PLUS FIN PUNCH - SZ 3-4 L
00885556739310MEDIAL PLUS FIN PUNCH - SZ 1-2 R
00885556739303MEDIAL PLUS FIN PUNCH - SZ 1-2 L
00885556739273JII CR TRIAL INSERT SZ 1-2 9MM L
00885556739150MODIFIED HOHMANN RETRACTOR
00885556739143JII CR TRIAL INSERT SZ 7-8 12MM R
00885556739136JII CR TRIAL INSERT SZ 7-8 11MM
00885556739129JII CR TRIAL INSERT SZ 7-8 10MM R
00885556739112JII CR TRIAL INSERT SZ 5-6 12MM R
00885556739105JII CR TRIAL INSERT SZ 5-6 11MM R
00885556739099JII CR TRIAL INSERT SZ 5-6 10MM R
00885556739082JII CR TRIAL INSERT SZ 3-4 12MM R
00885556739075JII CR TRIAL INSERT SZ 3-4 11MM R
00885556739068JII CR TRIAL INSERT SZ 3-4 10MM R
00885556739051JII CR TRIAL INSERT SZ 1-2 12MM R
00885556739044JII CR TRIAL INSERT SZ 1-2 11MM R
00885556739037JII CR TRIAL INSERT SZ 1-2 10MM R
00885556739013JII CR TRIAL INSERT SZ 5-6 9MM R
00885556738993JII CR TRIAL INSERT SZ 1-2 9MM R
00885556738801INSERTION HANDLE
00885556738795JII CR TRIAL INSERT SZ 7-8 12MM L
00885556738788JII CR TRIAL INSERT SZ 7-8 11MM L
00885556738771JII CR TRIAL INSERT SZ 7-8 10MM L
00885556738764JII CR TRIAL INSERT SZ 5-6 12MM L
00885556738757JII CR TRIAL INSERT SZ 5-6 11MM L
00885556738740JII CR TRIAL INSERT SZ 5-6 10MM L
00885556738733JII CR TRIAL INSERT SZ 3-4 12MM L
00885556738726JII CR TRIAL INSERT SZ 3-4 11MM L
00885556738719JII CR TRIAL INSERT SZ 3-4 10MM L
00885556738702JII CR TRIAL INSERT SZ 1-2 12MM L
00885556738696JII CR TRIAL INSERT SZ 1-2 11MM L
00885556738689JII CR TRIAL INSERT SZ 1-2 10MM L
00885556738672JII CR TRIAL INSERT SZ 7-8 9MM L
00885556738665JII CR TRIAL INSERT SZ 5-6 9MM L
00885556738658JII CR TRIAL INSERT SZ 3-4 9MM L

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