| Primary Device ID | 00885556661475 |
| NIH Device Record Key | e6a317d1-439a-4c53-b932-3b62daea1c5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Journey Uni |
| Version Model Number | E0015173-1 |
| Catalog Number | E0015173-1 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556661475 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
Moist Heat or Steam Sterilization
[00885556661475]
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 | 2016-10-14 |
| 00885556715178 | 3MM & 10MM TIBIA STYLUS |
| 00885556696903 | JOURNEY UNI TIBIAL CUTTING GUIDE RM/LL |
| 00885556696897 | JOURNEY UNI TIBIAL CUTTING GUIDE LM/RL |
| 00885556661482 | TIBIA RESECTOR BASE - RT MED / LT LAT |
| 00885556661475 | TIBIA RESECTOR BASE - LT MED / RT LAT |
| 00885556633311 | MODULAR IMPACTOR HEAD |
| 00885556633304 | FIN PUNCH SZ 5-6 |
| 00885556633298 | FIN PUNCH SZ 3-4 |
| 00885556633281 | FIN PUNCH SZ 1-2 |
| 00885556633274 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 RM/LL |
| 00885556633267 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 RM/LL |
| 00885556633250 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 RM/LL |
| 00885556633243 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 RM/LL |
| 00885556633236 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 RM/LL |
| 00885556633229 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 RM/LL |
| 00885556633212 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LM/RL |
| 00885556633205 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LM/RL |
| 00885556633199 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LM/RL |
| 00885556633182 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LM/RL |
| 00885556633175 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LM/RL |
| 00885556633168 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LM/RL |
| 00885556623541 | FIN PUNCH SZ 5-6 |
| 00885556623534 | FIN PUNCH SZ 3-4 |
| 00885556623527 | FIN PUNCH SZ 1-2 |
| 00885556623510 | MODULAR IMPACTOR HEAD |
| 00885556623503 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LL/RM |
| 00885556623497 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LL/RM |
| 00885556623480 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LL/RM |
| 00885556616918 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LM/RL |
| 00885556616901 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 3 LL/RM |
| 00885556616895 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LL/RM |
| 00885556616888 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LL/RM |
| 00885556616871 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 6 LM/RL |
| 00885556616864 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 5 LM/RL |
| 00885556616857 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 4 LM/RL |
| 00885556616840 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 2 LM/RL |
| 00885556616833 | UNI TRIAL TIB BASE W/ FIN SLOT SZ 1 LM/RL |