JOURNEY II XR 74023810

GUDID 00885556615508

JOURNEY II XR ART INSERT XLPE LAT SZ 1-2 RT 8MM

Smith & Nephew, Inc.

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: 00885556615508
• NIH Device Record Key: 1dc85af4-db77-48eb-9bf1-59772e570aba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOURNEY II XR
• Version Model Number: 74023810
• Catalog Number: 74023810
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556615508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152726

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-25

On-Brand Devices [JOURNEY II XR]

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