JOURNEY 74013421
GUDID 03596010626868
JOURNEY UNI FIXED BEARING FEMORAL TRIAL LEFT MEDIAL SZ 1
Smith & Nephew, Inc.
General internal orthopaedic fixation system implantation kit| Primary Device ID | 03596010626868 |
| NIH Device Record Key | 3e9bdaab-2ced-4109-a24d-df12cc9465c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JOURNEY |
| Version Model Number | 74013421 |
| Catalog Number | 74013421 |
| 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)821-5700 |
| 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 | |
| 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 | 03596010626868 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113038
FDA Product Code
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
[03596010626868]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-31 |
| 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]
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