| Primary Device ID | 00885556621677 |
| NIH Device Record Key | a6a0c82c-e51d-472c-ba47-0283d3cdef45 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZUK |
| Version Model Number | 00584305400 |
| Catalog Number | 00584305400 |
| 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 | 00885556621677 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
[00885556621677]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-06-22 |
| Device Publish Date | 2016-02-15 |
| 00885556731475 | ZUK SPACER BLOCK 11MM |
| 00885556731468 | ZUK SPCER BLOCK 9MM |
| 00885556728871 | ZUK SPACER BLOCK - 9MM |
| 00885556728864 | ZUK SPACER BLOCK - 11MM |
| 00885556717264 | RT 5-6 UNI TIBIA SIZER AND DRILL GUIDE |
| 00885556717257 | RT 3-4 UNI TIBIA SIZER AND DRILL GUIDE |
| 00885556717240 | RT 1-2 UNI TIBIA SIZER AND DRILL GUIDE |
| 00885556717233 | LT 5-6 UNI TIBIA SIZER AND DRILL GUIDE |
| 00885556717226 | LT 3-4 UNI TIBIA SIZER AND DRILL GUIDE |
| 00885556717219 | LT 1-2 UNI TIBIA SIZER AND DRILL GUIDE |
| 00885556717202 | RT UNI TIBIA KEEL PUNCH |
| 00885556717196 | LT UNI TIBIA KEEL PUNCH |
| 00885556716113 | ZUK SPACER BLOCK - 11MM |
| 00885556716106 | ZUK SPACER BLOCK - 9MM |
| 00885556689813 | ZUK FEMORAL/TIBIAL COMBINED SIZER LL/RM |
| 00885556689806 | ZUK FEMORAL/TIBIAL COMBINED SIZER LM/RL |
| 00885556689790 | ZUK TIBIAL SIZING TEMPLATE SZ 6 |
| 00885556689783 | ZUK TIBIAL SIZING TEMPLATE SZ 5 |
| 00885556689769 | ZUK TIBIAL SIZING TEMPLATE SZ 3 |
| 00885556689752 | ZUK TIBIAL SIZING TEMPLATE SZ 2 |
| 00885556689745 | ZUK TIBIAL SIZING TEMPLATE SZ 1 |
| 00885556689707 | ZUK SPACER BLOCK - 11MM |
| 00885556689691 | ZUK SPACER BLOCK - 9MM |
| 00885556689639 | ZUK SPACER BLOCK - 9MM |
| 00885556658222 | SMITH AND NEPHEWS ZUK TRAY LID |
| 00885556658215 | TIBIA INSTRUMENT AND TRIAL TRAY |
| 00885556658208 | TIBIA INSTRUMENT TRAY |
| 00885556658192 | FEMORAL INSTRUMENT TRAY |
| 00885556657744 | ZUK SPACER BLOCK - 9MM |
| 00885556657737 | ZUK SPACER BLOCK - 11MM |
| 00885556657720 | ZUK SPACER BLOCK - 11MM |
| 00885556657713 | ZUK SPACER BLOCK - 9MM |
| 00885556621813 | Long Headless Smooth Pin Gold |
| 00885556621806 | ZUK Ankle Clamp |
| 20885556621794 | MIS Z Retractor |
| 00885556621783 | MIS Small PCL Retractor |
| 00885556621776 | MIS Quad-Sparing Screw Inserter Extractor |
| 00885556621769 | MIS Quad-Sparing Headed Screw 48 MM Length |
| 00885556621752 | MIS Quad-Sparing Headed Screw 33 MM Length |
| 00885556621745 | Tibial Resection Guide |
| 20885556621732 | ZUK Short Headed Holding Pin 17mm |
| 20885556621725 | ZUK Short Headed Holding Pin |
| 20885556621718 | ZUK Short Headed Holding Pin 52mm |
| 00885556621691 | Headless Trocar Drill Pin 3.2 MM Diameter 75 MM Length |
| 00885556621684 | 2MM FEMORAL/TIBIAL RECUTTER |
| 00885556621677 | ZUK Insertion Handle |
| 00885556621660 | Tray/Articular Surface Inserter Tip |
| 00885556621653 | ZUK Articular Surface Inserter Handle |
| 00885556621646 | Zimmer Unicompartmental Femoral Reamer .270 |
| 00885556621639 | Tibial Sizing Slider |