| Primary Device ID | 00885556706718 |
| NIH Device Record Key | 6089cad7-c1e1-43f1-a2f8-426e2af1d89e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Journey II Uni |
| Version Model Number | E0015701-7 |
| Catalog Number | E0015701-7 |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556706718 [Primary] |
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
[00885556706718]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2018-01-29 |
| 00885556709702 | ANKLE CLAMP |
| 00885556709696 | TIBIAL ALIGNMENT TUBE |
| 00885556706787 | TIBIAL SHIM RM/LL - CAPTURED |
| 00885556706770 | TIBIAL SHIM LM/RL - CAPTURED |
| 00885556706763 | TIBIAL SHIM RM/LL - UNCAPTURED |
| 00885556706756 | TIBIAL SHIM LM/RL - UNCAPTURED |
| 00885556706749 | TIBIAL HEAD RM/LL |
| 00885556706732 | TIBIAL HEAD LM/RL |
| 00885556706725 | SPOON - 3MM |
| 00885556706718 | SPOON - 2MM |
| 00885556706701 | SPOON - 1MM |
| 00885556706695 | CONNECTOR - 8MM |
| 00885556706688 | ANKLE CLAMP |
| 00885556706671 | TIBIAL ALIGNMENT TUBE |
| 00885556696668 | NON ROTATING TIBIAL STYLUS 6MM / 8MM |
| 00885556696651 | NON ROTATING TIBIAL STYLUS 2MM / 4MM |
| 00885556686935 | UNI FEMORAL TRIAL IMPACTOR / HOLDER |
| 00885556696569 | TIBIA CONNECTOR 8 MM CLOSED ALTERNATE |
| 00885556696453 | LM/RL MODULAR SHIM CAPTURED |
| 00885556696446 | LM/RL MODULAR SHIM UNCAPTURED |
| 00885556696439 | RM/LL MODULAR SHIM CAPTURED |
| 00885556696422 | RM/LL MODULAR SHIM UNCAPTURED |
| 00885556696415 | RM/LL TIBIA RESECTION GUIDE ALTERNATE |
| 00885556696408 | LM/RL TIBIA RESECTION GUIDE ALTERNATE |
| 00885556696293 | FIXED ANKLE CLAMP |
| 00885556692424 | JOURNEY II UNI LAT TIBIA INSERT TRIAL SZ 4-5 11MM |
| 00885556692271 | 17MM PIN - NON STERILE |
| 00885556692264 | JOURNEY II UNI FEMORAL TRIAL HOLDER |
| 00885556692257 | FEMORAL FREE IMPACTOR |
| 00885556692240 | 3.5mm LOCKING HEX T-HANDLE |
| 00885556692233 | FEMORAL PEG DRILL |
| 00885556692226 | JOURNEY II UNI TIBIA SIZING HOOK |
| 00885556692202 | TIBIA FREE IMPACTOR |
| 00885556692196 | INSERT IMPLANT LOCKING TOOL |
| 00885556692127 | KEEL PUNCH |
| 00885556691946 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 14MM |
| 00885556691939 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 13MM |
| 00885556691922 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 12MM |
| 00885556691915 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 11MM |
| 00885556691908 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 10MM |
| 00885556691892 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 9MM |
| 00885556691885 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 9-10 8MM |
| 00885556691786 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 14MM |
| 00885556691779 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 13MM |
| 00885556691762 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 12MM |
| 00885556691755 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 11MM |
| 00885556691748 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 10MM |
| 00885556691731 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 9MM |
| 00885556691724 | JOURNEY II UNI MED TIBIA INSERT TRIAL SZ 7-8 8MM |
| 00885556691694 | JOURNEY II UNI LAT TIBIA INSERT TRIAL SZ 6-7 14MM |