| Primary Device ID | 00817906028195 |
| NIH Device Record Key | 7138ed05-bd1d-4f84-a6dd-1430d45620e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 5MS |
| Version Model Number | P06 N0581 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817906028195 [Primary] |
| HWC | Screw, Fixation, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817906028195]
Moist Heat or Steam Sterilization
[00817906028195]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-10-22 |
| 00817906028317 | 5MS, PLANTAR PLATE, LARGE, TRIAL, 4H |
| 00817906028300 | 5MS, PLANTAR PLATE, LARGE, TRIAL, 5H |
| 00817906028294 | 5MS, PSEUDO JONES PLATE TRIAL |
| 00817906028287 | 5MS, BUNIONETTE PLATE, L, TRIAL |
| 00817906028270 | 5MS, BUNIONETTE PLATE, R, TRIAL |
| 00817906028263 | 5MS, LATERAL NECK PLATE, 6H, L, TRIAL |
| 00817906028256 | 5MS, LATERAL NECK PLATE, 8H, L, TRIAL |
| 00817906028249 | 5MS, LATERAL NECK PLATE, 6H, R, TRIAL |
| 00817906028232 | 5MS, LATERAL NECK PLATE, 8H, R, TRIAL |
| 00817906028225 | 5MS, PLANTAR PLATE, TRIAL, 4H |
| 00817906028218 | 5MS, PLANTAR PLATE, TRIAL, 5H |
| 00817906028201 | COMPRESSION DRILL GUIDE, Ø2.0 & Ø2.5, ASSY |
| 00817906028195 | COMPRESSION DRILL GUIDE, Ø1.6 & Ø1.9, ASSY |
| 00817906028188 | 5MS, PSEUDO JONES PLATE TAMP |
| 00817906028171 | 5MS, LOCKING DRILL GUIDE, Ø1.9 |
| 00817906028164 | 5MS, LOCKING DRILL GUIDE, Ø1.6 |
| 00817906028157 | 5MS, JONES SCREW SIZER |