JOURNEY 74035751
GUDID 00885556534243
JOURNEY II INSERT TRIAL DEEP DISHED RIGHT 5-6 9MM
Smith & Nephew, Inc.
Knee tibia prosthesis trial| Primary Device ID | 00885556534243 |
| NIH Device Record Key | 81faf7fe-4b35-4472-9664-6a9fb52ab82e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JOURNEY |
| Version Model Number | 74035751 |
| Catalog Number | 74035751 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556534243 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113482
FDA Product Code
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
[00885556534243]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2015-08-29 |
On-Brand Devices [JOURNEY]
| 00885556741535 | LOW PROFILE CEMENT CLAMP |
| 00885556740866 | PATELLA RESECTION GUIDE |
| 00885556740828 | FLEXIBLE IM ROD |
| 00885556740811 | ANTERIOR FEMORAL CUTTING BLOCK |
| 00885556740804 | DISTAL FEMORAL RESECTION CHECK |
| 00885556740798 | DISTAL ALIGNMENT GUIDE - RIGHT |
| 00885556740781 | DISTAL ALIGNMENT GUIDE - LEFT |
| 00885556740774 | DISTAL RESECTION BLOCK - RIGHT |
| 00885556740767 | DISTAL RESECTION BLOCK - LEFT |
| 00885556740750 | DISTAL ALIGNMENT OFFSET ROD - RIGHT |
| 00885556740743 | DISTAL ALIGNMENT OFFSET ROD - LEFT |
| 00885556740736 | NEUTRAL DISTAL ALIGNMENT OFFSET ROD |
| 00885556737705 | FEMORAL SIZING GUIDE - RIGHT |
| 00885556737699 | FEMORAL SIZING GUIDE - LEFT |
| 00885556737682 | TIBIA CUTTING BLOCK - RIGHT |
| 00885556737675 | TIBIA CUTTING BLOCK - LEFT |
| 00885556737668 | FEMORAL SIZING STYLUS |
| 00885556735923 | ADJUSTABLE TIBIA STYLUS |
| 00885556719169 | 2MM RECUT BLOCK |
| 00885556714539 | SIZING GUIDE WITH SHORT PADDLES - RIGHT |
| 00885556714522 | SIZING GUIDE WITH SHORT PADDLES - LEFT |
| 00885556713419 | MODIFIED TIBIAL ALIGNMENT TUBE |
| 00885556707555 | 2MM RECUT BLOCK |
| 00885556697733 | FEMORAL NOTCH PREP GUIDE SZ 9~10 |
| 00885556697726 | FEMORAL NOTCH PREP GUIDE SZ 6~8 |
| 00885556697719 | FEMORAL NOTCH PREP GUIDE SZ 3~5 |
| 00885556697702 | FEMORAL NOTCH PREP GUIDE SZ 1~2 |
| 00885556697696 | BUMPER 9-10 R |
| 00885556697689 | BUMPER 9-10 L |
| 00885556697672 | BUMPER 1-8 R |
| 00885556697665 | BUMPER 1-8 L |
| 00885556697658 | JOURNEY CR FEMORAL IMPACTOR |
| 00885556697450 | FLEXIBLE IM ROD |
| 00885556697405 | NO ROTATION JOURNEY SIZING STYLUS |
| 00885556697146 | LOW PROFILE DONUT PATELLA CLAMP |
| 00885556694176 | JOURNEY RESURFACING PATELLAR DRILL |
| 00885556693087 | RIGHT TISSUE SPARING POSTERIOR PADDLES |
| 00885556693070 | LEFT TISSUE SPARING POSTERIOR PADDLES |
| 00885556692677 | JOURNEY LOCKING TIBIAL IMPACTOR |
| 00885556692325 | RIGHT MODIFIED TIBIAL CUTTING BLOCK |
| 00885556692318 | LEFT MODIFIED TIBIAL CUTTING BLOCK |
| 00885556689899 | PATELLA DRILL GUIDE 38-41MM |
| 00885556689882 | PATELLA DRILL GUIDE 32-35MM |
| 00885556689875 | PATELLA DRILL GUIDE 26-29MM |
| 00885556689868 | PATELLA CLAMP LEVER |
| 00885556689196 | TIBIAL TRIAL INSERT FORK HANDLE |
| 00885556687413 | XR ANTERIOR EMINENCE CHISEL GUIDE LONG |
| 00885556685990 | TIBIAL STYLUS WITH SPRING FOOT 2MM/9MM |
| 00885556685983 | NONSLOTTED 3 DEG TIBIA BLOCK RIGHT |
| 00885556685976 | NONSLOTTED 3 DEG TIBIA BLOCK LEFT |
Trademark Results [JOURNEY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 JOURNEY 98864349 not registered Live/Pending |
ETL, LLC 2024-11-20 |
 JOURNEY 98755801 not registered Live/Pending |
Journey Skilled Nursing, LLC 2024-09-17 |
 JOURNEY 98384623 not registered Live/Pending |
Hall Labs, LLC 2024-01-31 |
 JOURNEY 98365225 not registered Live/Pending |
Franklin Sports, Inc. 2024-01-19 |
 JOURNEY 97646875 not registered Live/Pending |
Capital One Financial Corporation 2022-10-25 |
 JOURNEY 97504375 not registered Live/Pending |
Novi Limited 2022-07-14 |
 JOURNEY 97434286 not registered Live/Pending |
League, Inc. 2022-05-30 |
 JOURNEY 97174378 not registered Live/Pending |
Hevo Incorporated 2021-12-15 |
 JOURNEY 97108018 not registered Live/Pending |
Smith Mountain Industries, Inc. 2021-11-04 |
 JOURNEY 90898392 not registered Live/Pending |
The Upper Deck Company 2021-08-24 |
 JOURNEY 90695582 not registered Live/Pending |
Worthy Technology LLC 2021-05-07 |
 JOURNEY 90643055 not registered Live/Pending |
Jetson Electric Bikes LLC 2021-04-13 |
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