| Primary Device ID | 10705034576749 |
| NIH Device Record Key | 4cd5bc46-4146-4958-a249-2a00f5fb99b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 698344972 |
| Catalog Number | 698344972 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, 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 | 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)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 | 10705034576749 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
[10705034576749]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-19 |
| Device Publish Date | 2024-09-11 |
| 10705034538891 | MODIFIED INSTRUMENT DISTRACTOR |
| 10705034501031 | MODIFIED INSTRUMENT DRIVER X25 |
| 10705034498652 | MODIFIED INSTRUMENT INSERTER X25 |
| 10705034487601 | MODIFIED INSTRUMENT XTAB THREADED DISTRACTION POST |
| 10705034534237 | MODIFIED INSTRUMENT CURETTE, STRAIGHT 6.5mm |
| 10705034533841 | MODIFIED INSTRUMENT DOWN BITING CURETTE |
| 10705034500645 | MODIFIED INSTRUMENT INTERVERTEBRAL DISC SHAVER 14mm |
| 10705034558820 | MODIFIED INSTRUMENT TWO-HANDED ELLIPTICAL HANDLE |
| 10705034313160 | MODIFIED INSTRUMENT PLATE HOLDER TIP |
| 10705034547893 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 8mm |
| 10705034547657 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 9mm |
| 10705034547428 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 11mm |
| 10705034547244 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 12mm |
| 10705034547206 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 13mm |
| 10705034547114 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 17mm |
| 10705034547008 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 10mm |
| 10705034546971 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 7mm |
| 10705034546933 | MODIFIED INSTRUMENT PLIF TRIAL SPACER 15mm |
| 10705034543871 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 13mm |
| 10705034543864 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 17mm |
| 10705034543833 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 12mm |
| 10705034543802 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 14mm |
| 10705034543796 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 11mm |
| 10705034543710 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 10mm |
| 10705034543703 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 8mm |
| 10705034543680 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 16mm |
| 10705034543673 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 9mm |
| 10705034543666 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 7mm |
| 10705034543642 | MODIFIED INSTRUMENT STRAIGHT PLIF SPREADER 15mm |
| 10705034560748 | MODIFIED INSTRUMENT ENDPLATE ELEVATOR 10mm |
| 10705034547886 | MODIFIED INSTRUMENT DRILL GUIDE 12mm |
| 10705034547787 | MODIFIED INSTRUMENT DRILL GUIDE 18mm |
| 10705034547510 | MODIFIED INSTRUMENT DRILL GUIDE 16mm |
| 10705034547398 | MODIFIED INSTRUMENT DRILL GUIDE 14mm |
| 10705034547299 | MODIFIED INSTRUMENT EXPANSION HEAD SCREWDRIVER |
| 10705034546940 | MODIFIED INSTRUMENT SCREWDRIVER X15 |
| 10705034543857 | MODIFIED INSTRUMENT DOUBLE BARREL DRILL GUIDE |
| 10705034543734 | MODIFIED INSTRUMENT FACILITATOR |
| 10705034543697 | MODIFIED INSTRUMENT FIXED T-HANDLE DRIVER X25 |
| 10705034542942 | MODIFIED INSTRUMENT UP-BITING CURETTE 3.5mm |
| 10705034542812 | MODIFIED INSTRUMENT CERVICAL DISTRACTOR |
| 10705034542713 | MODIFIED INSTRUMENT ROD OSTEOTOME |
| 10705034536736 | MODIFIED INSTRUMENT QUICK STICK FLEX CLIP |
| 10705034536637 | MODIFIED INSTRUMENT QUICK STICK DRIVER T25 |
| 10705034536613 | MODIFIED INSTRUMENT QUICK STICK REDUCER |
| 10705034535753 | MODIFIED INSTRUMENT BONE IMPACTOR |
| 10705034535371 | MODIFIED INSTRUMENT IMPACTOR |
| 10705034501154 | MODIFIED INSTRUMENT PEDICLE PROBE |
| 10705034546902 | MODIFIED INSTRUMENT DRILL GUIDE |
| 10705034534282 | MODIFIED INSTRUMENT MESH INSERTER, CURVED |