Journey Uni E0014599-9

GUDID 00885556616901

UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LL/RM

Smith & Nephew, Inc.

Knee tibia prosthesis trial
Primary Device ID00885556616901
NIH Device Record Key48f6f993-f730-42de-b80a-d1182c67843a
Commercial Distribution StatusIn Commercial Distribution
Brand NameJourney Uni
Version Model NumberE0014599-9
Catalog NumberE0014599-9
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
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
GS100885556616901 [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

[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


[00885556616901]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2015-12-11

On-Brand Devices [Journey Uni]

008855567151783MM & 10MM TIBIA STYLUS
00885556696903JOURNEY UNI TIBIAL CUTTING GUIDE RM/LL
00885556696897JOURNEY UNI TIBIAL CUTTING GUIDE LM/RL
00885556661482TIBIA RESECTOR BASE - RT MED / LT LAT
00885556661475TIBIA RESECTOR BASE - LT MED / RT LAT
00885556633311MODULAR IMPACTOR HEAD
00885556633304FIN PUNCH SZ 5-6
00885556633298FIN PUNCH SZ 3-4
00885556633281FIN PUNCH SZ 1-2
00885556633274UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 RM/LL
00885556633267UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 RM/LL
00885556633250UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 RM/LL
00885556633243UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 RM/LL
00885556633236UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 RM/LL
00885556633229UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 RM/LL
00885556633212UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LM/RL
00885556633205UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LM/RL
00885556633199UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LM/RL
00885556633182UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LM/RL
00885556633175UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LM/RL
00885556633168UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LM/RL
00885556623541FIN PUNCH SZ 5-6
00885556623534FIN PUNCH SZ 3-4
00885556623527FIN PUNCH SZ 1-2
00885556623510MODULAR IMPACTOR HEAD
00885556623503UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LL/RM
00885556623497UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LL/RM
00885556623480UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LL/RM
00885556616918UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LM/RL
00885556616901UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LL/RM
00885556616895UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LL/RM
00885556616888UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LL/RM
00885556616871UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LM/RL
00885556616864UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LM/RL
00885556616857UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LM/RL
00885556616840UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LM/RL
00885556616833UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LM/RL

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