| Primary Device ID | 00191083044576 |
| NIH Device Record Key | 27d21dfa-b3f4-489d-9354-e8ff90650a85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Meniscus Allograft Transplantation (MAT) |
| Version Model Number | 999012 |
| Catalog Number | 999012 |
| Company DUNS | 117560455 |
| Company Name | Rti Surgical, Inc. |
| 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(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com | |
| Phone | +1(386)418-8888 |
| labeling@rtix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00191083044576 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
[00191083044576]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-22 |
| Device Publish Date | 2024-10-14 |
| 00191083047850 | MAT Instrument Tray |
| 00191083044606 | Non-Ratching 1/4" square connector |
| 00191083044583 | Pusher |
| 00191083044576 | Handle (Guide Drill Assembly) |
| 00191083044569 | Drill Chuck |
| 00191083044552 | Drill 7mm |
| 00191083044545 | Drill 8mm |
| 00191083044538 | Box Cutter 7 mm |
| 00191083044521 | Box Cutter 8mm |
| 00191083044514 | Rasp 7mm |
| 00191083044507 | Rasp 8mm |
| 00191083044491 | Depth Gauge |
| 00191083044484 | Guide Drill |
| 00191083044477 | Insertion Pin |
| 00191083044460 | U Pin |
| 00191083044446 | Graft Sizer Base |