| Primary Device ID | H679040010020 | 
| NIH Device Record Key | 3a3a9931-a6cf-4e66-91fc-51804fd13c37 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EXPert Nail | 
| Version Model Number | 04.001.002 | 
| Catalog Number | 04001002 | 
| Company DUNS | 832637081 | 
| Company Name | SYNTHES (U.S.A.) LP | 
| 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 | true | 
| 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)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | |
| Phone | +1(800)255-2500 | 
| xx@xx.xx | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10886982080769 [Primary] | 
| HIBCC | H679040010020 [Secondary] | 
| JDS | NAIL, FIXATION, BONE | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
[H679040010020]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 5 | 
| Public Version Date | 2021-04-07 | 
| Device Publish Date | 2015-09-14 | 
| 07611819498860 | RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/175MM | 
| 07611819498853 | RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM | 
| H67904031003S0 | TI END CAP T40 STRDRV 15MM EXT FOR ADOLESCENT LFN-EX-STER | 
| H679040310030 | TI END CAP T40 STRDRV 15MM EXT FOR ADOLESCENT LFN-EX | 
| H67904031002S0 | TI END CAP T40 STRDRV 10MM EXT FOR ADOLESCENT LFN-EX-STER | 
| H679040310020 | TI END CAP T40 STRDRV 10MM EXT FOR ADOLESCENT LFN-EX | 
| H67904031001S0 | TI END CAP T40 STRDRV 5MM EXT FOR ADOLESCENT LFN-EX-STER | 
| H679040310010 | TI END CAP T40 STRDRV 5MM EXT FOR ADOLESCENT LFN-EX | 
| H67904031000S0 | TI END CAP T40 STRDRV 0MM EXT FOR ADOLESCENT LFN-EX-STER | 
| H679040310000 | TI END CAP T40 STRDRV 0MM EXT FOR ADOLESCENT LFN-EX | 
| H679040130000 | TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD | 
| H67904008001S0 | TI END CAP T25 STRDRV HINDFOOT ARTHRODESIS NAIL-EX - STERILE | 
| H679040080010 | TI END CAP T25 STRDRV HINDFOOT ARTHRODESIS NAIL-EX | 
| H67904008000S0 | TI END CAP T25 STRDRV HINDFOOT ARTHRO NAIL-EX SPRL BLD-STER | 
| H67904004011S0 | TI END CAP FOR TIBIAL NAILS-EX T40 STRDRV GRAY/15MM EXT-STER | 
| H679040040110 | TI END CAP FOR TIBIAL NAILS-EX T40 STARDRIVE GRAY/15MM EXT | 
| H67904004010S0 | TI END CAP FOR TIBIAL NAILS-EX T40 STRDRV GRAY/10MM EXT-STER | 
| H679040040100 | TI END CAP FOR TIBIAL NAILS-EX T40 STARDRIVE GRAY/10MM EXT | 
| H67904004009S0 | TI END CAP FOR TIBIAL NAILS-EX T40 STRDRV GRAY/5MM EXT-STER | 
| H679040040090 | TI END CAP FOR TIBIAL NAILS-EX T40 STARDRIVE GRAY/5MM EXT | 
| H67904004008S0 | TI END CAP FOR TIBIAL NAILS-EX T40 STRDRV GRAY/0MM EXT-STER | 
| H679040040080 | TI END CAP FOR TIBIAL NAILS-EX T40 STARDRIVE GRAY/0MM EXT | 
| H67904004003S0 | TI END CAP W/T40 STRDRV 15MM EXT-STER F/TI TIBIAL NAILS-EX | 
| H679040040030 | TI END CAP WITH T40 STARDRIVE 15MM EXT F/TI TIBIAL NAILS-EX | 
| H67904004002S0 | TI END CAP W/T40 STRDRV 10MM EXT-STER F/TI TIBIAL NAILS-EX | 
| H679040040020 | TI END CAP WITH T40 STARDRIVE 10MM EXT F/TI TIBIAL NAILS-EX | 
| H679040040010 | TI END CAP WITH T40 STARDRIVE 5MM EXT F/TI TIBIAL NAILS-EX | 
| H67904004000S0 | TI END CAP W/T40 STRDRV 0MM EXT-STER F/TI TIBIAL NAILS-EX | 
| H679040030090 | 16MM TI END CAP T40 STARDRIVE 20MM EXT FOR FEMORAL NAILS-EX | 
| H679040030080 | 16MM TI END CAP T40 STARDRIVE 15MM EXT FOR FEMORAL NAILS-EX | 
| H67904003007S0 | 16MM TI END CAP T40 STARDRIVE 10MM EXT-STER/FEMORAL NAILS-EX | 
| H679040030070 | 16MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX | 
| H67904003006S0 | 16MM TI END CAP T40 STARDRIVE 5MM EXT-STER/FEMORAL NAILS-EX | 
| H67904003004S0 | 12MM TI END CAP T40 STARDRIVE 20MM EXT-STER/FEMORAL NAILS-EX | 
| H679040030040 | 12MM TI END CAP T40 STARDRIVE 20MM EXT FOR FEMORAL NAILS-EX | 
| H67904003003S0 | 12MM TI END CAP T40 STARDRIVE 15MM EXT-STER/FEMORAL NAILS-EX | 
| H679040030030 | 12MM TI END CAP T40 STARDRIVE 15MM EXT FOR FEMORAL NAILS-EX | 
| H67904003002S0 | 12MM TI END CAP T40 STARDRIVE 10MM EXT-STER/FEMORAL NAILS-EX | 
| H679040030020 | 12MM TI END CAP T40 STARDRIVE 10MM EXT FOR FEMORAL NAILS-EX | 
| H67904003001S0 | 12MM TI END CAP T40 STARDRIVE 5MM EXT-STER/FEMORAL NAILS-EX | 
| H679040030010 | 12MM TI END CAP T40 STARDRIVE 5MM EXT FOR FEMORAL NAILS-EX | 
| H67904003000S0 | TI END CAP T40 STRDRV 0MM EXT STERILE FOR FEMORAL NAILS-EX | 
| H679040030000 | TI END CAP T40 STARDRIVE 0MM EXT FOR FEMORAL NAILS-EX | 
| H67904001003S0 | TI END CAP T25 STRDRV 15MM EXT STER/HUMERAL NAIL-EX SPRL BLD | 
| H679040010030 | TI END CAP T25 STRDRV 15MM EXT HUMERAL NAIL-EX SPIRAL BLADE | 
| H67904001002S0 | TI END CAP T25 STRDRV 10MM EXT STER/HUMERAL NAIL-EX SPRL BLD | 
| H679040010020 | TI END CAP T25 STRDRV 10MM EXT HUMERAL NAIL-EX SPIRAL BLADE | 
| H67904001001S0 | TI END CAP T25 STRDRV 5MM EXT- STER/HUMERAL NAIL-EX SPRL BLD | 
| H679040010010 | TI END CAP T25 STRDRV 5MM EXT HUMERAL NAIL-EX SPIRAL BLADE | 
| H679040010000 | TI END CAP T25 STRDRV 0MM EXT HUMERAL NAIL-EX SPIRAL BLADE | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EXPERT NAIL  79018651  3251941 Dead/Cancelled | DePuy Synthes, Inc. 2005-05-03 |