JOURNEY II XR 74013978

GUDID 00885556695937

JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 1

Smith & Nephew, Inc.

Knee tibia prosthesis trial
Primary Device ID00885556695937
NIH Device Record Keyd1d80daf-7487-44aa-afa9-68e7771e22aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameJOURNEY II XR
Version Model Number74013978
Catalog Number74013978
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556695937 [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

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

[00885556695937]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2018-02-06

On-Brand Devices [JOURNEY II XR]

00885556698020JOURNEY II XR TIBIAL DRILL GUIDE SIZE 7-8
00885556698013JOURNEY II XR TIBIAL DRILL GUIDE SIZE 5-6
00885556698006JOURNEY II XR TIBIAL DRILL GUIDE SIZE 3-4
00885556697993JOURNEY II XR TIBIAL DRILL GUIDE SIZE 1-2
00885556696088JOURNEY II XR TIBIAL KEEL DRILL
00885556696064JOURNEY II XR TIBIAL ANTERIOR KEEL PUNCH SZ 3-8
00885556696057JOURNEY II XR TIBIAL ANTERIOR KEEL PUNCH SZ 1-2
00885556696040JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 7-8
00885556696033JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 5-6
00885556696026JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 3-4
00885556696019JOURNEY II XR TIBIAL POSTERIOR KEEL PUNCH SZ 1-2
00885556696002JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 8
00885556695999JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 7
00885556695982JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 6
00885556695975JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 5
00885556695968JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 4
00885556695951JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 3
00885556695944JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 2
00885556695937JOURNEY II XR TIBIAL PUNCH GUIDE SIZE 1
00885556695920JOURNEY II XR INSERT HOLDER CADDY
00885556695913JOURNEY II XR TIBIAL FULL PUNCH TRAY
00885556694008JOURNEY II XR TIBIAL PIN AND PUNCH TRAY
00885556693995JOURNEY II XR MAIN INSTRUMENT TRAY
00885556692561JOURNEY II XR TIB BASE COVER SZ 7-8
00885556692554JOURNEY II XR TIB BASE COVER SZ 5-6
00885556692547JOURNEY II XR TIB BASE COVER SZ 3-4
00885556692530JOURNEY II XR TIB BASE COVER SZ 1-2
00885556689226JII XR FINAL KEEL PUNCH SIZE 5-6
00885556689219JII XR FINAL KEEL PUNCH SIZE 3-4
00885556689141XR TIBIAL INSERT TRIAL SZ 1-2 LT LATERAL -2 DEG 11MM
00885556689134XR TIBIAL INSERT TRIAL SZ 7-8 RT LATERAL -2 DEG 12MM
00885556689127XR TIBIAL INSERT TRIAL SZ 7-8 RT LATERAL -2 DEG 11MM
00885556689110XR TIBIAL INSERT TRIAL SZ 7-8 RT LATERAL -2 DEG 10MM
00885556689103XR TIBIAL INSERT TRIAL SZ 7-8 RT LATERAL -2 DEG 9MM
00885556689097XR TIBIAL INSERT TRIAL SZ 7-8 RT LATERAL -2 DEG 8MM
00885556689080XR TIBIAL INSERT TRIAL SZ 7-8 RT MEDIAL -2 DEG 12MM
00885556689073XR TIBIAL INSERT TRIAL SZ 7-8 RT MEDIAL -2 DEG 11MM
00885556689066XR TIBIAL INSERT TRIAL SZ 7-8 RT MEDIAL -2 DEG 10MM
00885556689059XR TIBIAL INSERT TRIAL SZ 7-8 RT MEDIAL -2 DEG 9MM
00885556689042XR TIBIAL INSERT TRIAL SZ 7-8 RT MEDIAL -2 DEG 8MM
00885556689035XR TIBIAL INSERT TRIAL SZ 7-8 LT LATERAL -2 DEG 12MM
00885556689028XR TIBIAL INSERT TRIAL SZ 7-8 LT LATERAL -2 DEG 11MM
00885556689011XR TIBIAL INSERT TRIAL SZ 7-8 LT LATERAL -2 DEG 10MM
00885556689004XR TIBIAL INSERT TRIAL SZ 7-8 LT LATERAL -2 DEG 9MM
00885556688991XR TIBIAL INSERT TRIAL SZ 7-8 LT LATERAL -2 DEG 8MM
00885556688984XR TIBIAL INSERT TRIAL SZ 7-8 LT MEDIAL -2 DEG 12MM
00885556688977XR TIBIAL INSERT TRIAL SZ 7-8 LT MEDIAL -2 DEG 11MM
00885556688960XR TIBIAL INSERT TRIAL SZ 7-8 LT MEDIAL -2 DEG 10MM
00885556688953XR TIBIAL INSERT TRIAL SZ 7-8 LT MEDIAL -2 DEG 9MM
00885556688946XR TIBIAL INSERT TRIAL SZ 7-8 LT MEDIAL -2 DEG 8MM
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