| Primary Device ID | 00817470010671 |
| NIH Device Record Key | c61ef933-c67d-4059-8165-4f74ee59677c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 21-8014 |
| Catalog Number | 21-8014 |
| 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)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com | |
| Phone | +1(800)821-5700 |
| gudid@smith-nephew.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817470010671 [Primary] |
| HXY | BRACE, DRILL |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817470010671]
Moist Heat or Steam Sterilization
[00817470010671]
Moist Heat or Steam Sterilization
[00817470010671]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2015-08-30 |
| 20817470011634 | PASSING PIN W DRILL TIP 425MM(17IN)X2.4MM |
| 00817470011401 | FINAL ASSY HANDSWITCH ARTHROCARE SRVC |
| 00817470011326 | FINAL ASSEMBLY POWER CORD DOMESTIC SRVC |
| 00817470011296 | FINAL ASSEMBLY POWER CORD INTL SRVC |
| 20817470011252 | TOURNIQUET LIMB DRAPE-SMALL |
| 20817470011245 | TOURNIQUET LIMB DRAPE |
| 00817470011166 | ANATOMIC ACL STERILIZATION TRAY |
| 00817470011159 | 2.8MM PATHFINDER |
| 00817470011142 | 1.8MM PATHFINDER |
| 00817470011135 | TIBIAL BUTTON IMPACTOR |
| 00817470011128 | TIBIAL DILATOR |
| 00817470011111 | 6.5MM TIBIAL DRILL |
| 00817470011098 | 7.0 - 8.5 TIBIAL PIN GUIDE BODY |
| 00817470011081 | KNOT PUSHER |
| 00817470011074 | 40MM PEEK TIBIAL IMPLANT |
| 00817470011067 | REUSABLE BONE PUNCH 2.8MM Q-FIX IMPLANT |
| 00817470011050 | DISPOSABLE KIT 2.8MM SHOULDER Q-FIX |
| 00817470011036 | DISPOSABLE KIT FOR 1.8MM SHOULDER Q-FIX |
| 00817470011029 | 2.8MM Q-FIX ALL SUTURE ANCHOR |
| 00817470011012 | 1.8MM Q-FIX ALL SUTURE ANCHOR |
| 00817470011005 | 33MM PEEK TIBIAL IMPLANT |
| 00817470010992 | N8TIVE ACL FEMORAL IMPLANT |
| 00817470010985 | ACL DISPOSABLE KIT |
| 00817470010930 | DEPTH GAGE |
| 00817470010923 | FEMORAL FOOTPRINT TEMPLATE |
| 00817470010916 | TIBIAL TAMP- SIZE 10.0 |
| 00817470010909 | TIBIAL TAMP- SIZE 9.5 |
| 00817470010893 | TIBIAL TAMP- SIZE 9.0 |
| 00817470010886 | TIBIAL TAMP- SIZE 8.5 |
| 00817470010879 | TIBIAL TAMP- SIZE 8.0 |
| 00817470010862 | TIBIAL TAMP- SIZE 7.5 |
| 00817470010855 | TIBIAL TAMP- SIZE 7.0 |
| 00817470010848 | TAMP EXTENDER |
| 00817470010831 | SLOTTED MALLET |
| 00817470010824 | FEMORAL TAMP SIZE 10.0 |
| 00817470010817 | FEMORAL TAMP SIZE 9.5 |
| 00817470010800 | FEMORAL TAMP SIZE 9.0 |
| 00817470010794 | FEMORAL TAMP SIZE 8.5 |
| 00817470010787 | FEMORAL TAMP SIZE 8.0 |
| 00817470010770 | FEMORAL TAMP SIZE 7.5 |
| 00817470010763 | FEMORAL TAMP SIZE 7.0 |
| 00817470010749 | TIBIAL SPACER INSERTER |
| 00817470010732 | IMPLANT EXTRACTOR |
| 00817470010725 | CURETTE |
| 00817470010718 | CLOSED TENDON HARVESTER |
| 00817470010701 | SLOTTED TENDON HARVESTER |
| 00817470010695 | GRAFT SIZING BLOCK |
| 00817470010688 | TUNNEL RASP |
| 00817470010671 | TIBIAL DRILL GUIDE ARM |
| 00817470010664 | TIBIAL PIN GUIDE |