| Primary Device ID | 00197169142129 |
| NIH Device Record Key | bb41ec38-3cc3-4b25-bec3-fb329813678d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Watson Extraction System |
| Version Model Number | 14212 |
| Catalog Number | 14212 |
| Company DUNS | 118921228 |
| Company Name | Simplex Designs, LLC |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00197169142129 [Primary] |
| HWM | Osteotome |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
[00197169142129]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-13 |
| Device Publish Date | 2023-03-04 |
| 00197169177015 | HEX T-HANDLE |
| 00197169176018 | STEM EXTRACTOR |
| 00197169175011 | THREADED T-HANDLE |
| 00197169174014 | STRIKE PLATE |
| 00197169173017 | SLIDE HAMMER WEIGHT |
| 00197169172010 | EXTRACTOR HANDLE |
| 00197169171303 | OSTEOTOME SIZER, 30 / 31 |
| 00197169171280 | OSTEOTOME SIZER, 28 / 29 |
| 00197169171266 | OSTEOTOME SIZER, 26 / 27 |
| 00197169171242 | OSTEOTOME SIZER, 24 / 25 |
| 00197169171228 | OSTEOTOME SIZER, 22 / 23 |
| 00197169171204 | OSTEOTOME SIZER, 20 / 21 |
| 00197169171181 | OSTEOTOME SIZER, 18 / 19 |
| 00197169171167 | OSTEOTOME SIZER, 16 / 17 |
| 00197169171143 | OSTEOTOME SIZER, 14 / 15 |
| 00197169171129 | OSTEOTOME SIZER, 12 / 13 |
| 00197169171112 | OSTEOTOME SIZER, TRUN / 11 |
| 00197169170016 | OSTEOTOME HANDLE |
| 00197169142280 | STRAIGHT MEDIAL OSTEOTOME, 28 |
| 00197169142273 | STRAIGHT MEDIAL OSTEOTOME, 27 |
| 00197169142266 | STRAIGHT MEDIAL OSTEOTOME, 26 |
| 00197169142259 | STRAIGHT MEDIAL OSTEOTOME, 25 |
| 00197169142242 | STRAIGHT MEDIAL OSTEOTOME, 24 |
| 00197169142235 | STRAIGHT MEDIAL OSTEOTOME, 23 |
| 00197169142228 | STRAIGHT MEDIAL OSTEOTOME, 22 |
| 00197169142211 | STRAIGHT MEDIAL OSTEOTOME, 21 |
| 00197169142204 | STRAIGHT MEDIAL OSTEOTOME, 20 |
| 00197169142198 | STRAIGHT MEDIAL OSTEOTOME, 19 |
| 00197169142181 | STRAIGHT MEDIAL OSTEOTOME, 18 |
| 00197169142174 | STRAIGHT MEDIAL OSTEOTOME, 17 |
| 00197169142167 | STRAIGHT MEDIAL OSTEOTOME, 16 |
| 00197169142150 | STRAIGHT MEDIAL OSTEOTOME, 15 |
| 00197169142143 | STRAIGHT MEDIAL OSTEOTOME, 14 |
| 00197169142136 | STRAIGHT MEDIAL OSTEOTOME, 13 |
| 00197169142129 | STRAIGHT MEDIAL OSTEOTOME, 12 |
| 00197169142112 | STRAIGHT MEDIAL OSTEOTOME, 11 |
| 00197169141313 | STRAIGHT LATERAL OSTEOTOME, 31 |
| 00197169141306 | STRAIGHT LATERAL OSTEOTOME, 30 |
| 00197169141290 | STRAIGHT LATERAL OSTEOTOME, 29 |
| 00197169141283 | STRAIGHT LATERAL OSTEOTOME, 28 |
| 00197169141276 | STRAIGHT LATERAL OSTEOTOME, 27 |
| 00197169141269 | STRAIGHT LATERAL OSTEOTOME, 26 |
| 00197169141252 | STRAIGHT LATERAL OSTEOTOME, 25 |
| 00197169141245 | STRAIGHT LATERAL OSTEOTOME, 24 |
| 00197169141238 | STRAIGHT LATERAL OSTEOTOME, 23 |
| 00197169141221 | STRAIGHT LATERAL OSTEOTOME, 22 |
| 00197169141214 | STRAIGHT LATERAL OSTEOTOME, 21 |
| 00197169141207 | STRAIGHT LATERAL OSTEOTOME, 20 |
| 00197169141191 | STRAIGHT LATERAL OSTEOTOME, 19 |
| 00197169141184 | STRAIGHT LATERAL OSTEOTOME, 18 |