Primary Device ID | 00817470010763 |
NIH Device Record Key | 898ec209-9585-450b-889f-9890f01dff08 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | N/A |
Version Model Number | 21-8070 |
Catalog Number | 21-8070 |
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 | 00817470010763 [Primary] |
HXG | TAMP |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00817470010763]
Moist Heat or Steam Sterilization
[00817470010763]
Moist Heat or Steam Sterilization
[00817470010763]
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 |