| Primary Device ID | 00819034029327 |
| NIH Device Record Key | 8b01c213-fcd2-4e97-9187-3a77cb442012 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LSI Arthroereisis Peg |
| Version Model Number | TN-LD-4001 |
| Catalog Number | TN-LD-4001 |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | true |
| 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 | 00819034029327 [Primary] |
| MJW | Prosthesis, Subtalar, Plug, Polymer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
[00819034029327]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-30 |
| Device Publish Date | 2020-11-20 |
| 00852164007995 | Trephine Long |
| 00819034029426 | Drill Guide Large |
| 00819034029419 | Drill Guide Medium |
| 00819034029402 | Drill Guide Small |
| 00819034029396 | Sizer Large Plus |
| 00819034029389 | Sizer Large |
| 00819034029372 | Sizer Medium Plus |
| 00819034029365 | Sizer Medium |
| 00819034029358 | Sizer Small Plus |
| 00819034029341 | Sizer Small |
| 00819034029334 | Starter Awl Right |
| 00819034029327 | TN-LD-4001 Starter Awl |
| 00819034029310 | Angled Awl 45 Degree |
| 00819034029303 | Trephine Short |
| 00819034029556 | LSI Implant Large Plus |
| 00819034029549 | LSI Implant Large |
| 00819034029532 | LSI ImplantMedium Plus |
| 00819034029525 | LSI Implant Medium |
| 00819034029518 | LSI Implant Small Plus |
| 00819034029501 | LSI Implant Small |
| 00819034029495 | Trial Large Plus |
| 00819034029488 | Trial Large |
| 00819034029471 | Trial Medium Plus |
| 00819034029464 | Trial Medium |
| 00819034029457 | Trial Small Plus |
| 00819034029440 | Trial Small |
| 00819034029433 | LSI Drill 4.9 mm |