JOURNEY II XR 74014535

GUDID 20885556242647

JOURNEY II XR TIBIAL SPEED PIN 6.5MM X 40MM

Smith & Nephew, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 20885556242647
• NIH Device Record Key: 5235e82c-f4ab-4bb9-a27b-2ea663389776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JOURNEY II XR
• Version Model Number: 74014535
• Catalog Number: 74014535
• 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
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• 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
• 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
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• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556242643 [Primary]
GS1	20885556242647 [Package]; Contains: 00885556242643; Package: BX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141471

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: 2016-03-15

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