| Primary Device ID | 20886705000460 |
| NIH Device Record Key | fceb51a0-6e33-4a84-a864-aea591534a0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FMS |
| Version Model Number | 287427 |
| Catalog Number | 287427 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 | |
| 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 | 10886705000463 [Primary] |
| GS1 | 20886705000460 [Package] Contains: 10886705000463 Package: PACKAGE [5 Units] In Commercial Distribution |
| HRX | ARTHROSCOPE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-07-04 |
| Device Publish Date | 2017-03-17 |
| 20886705016065 | FMS Waste Collection Bag |
| 20886705023230 | FMS Fluid Management System Outflow Tubing with One-Way valve (FMS VUE or FMS DUO Plus) |
| 30886705023220 | FMS Fluid Management System Outflow Tubing without One-Way valve (FMS VUE or FMS DUO Plus) |
| 30886705023060 | FMS Fluid Management System Inflow Tubing (FMS VUE) |
| 20886705017451 | FMS Fluid Management System Outflow Tubing with One-way valve (FMS DUO Plus) |
| 20886705017437 | FMS Patient Set Without One-Way Valve Arthroscopy Tubing |
| 10886705016358 | FMS Obturator for Cannulas 281580 |
| 20886705015907 | FMS Fluid Management System Intermediary Tubing with One-way valve |
| 20886705015853 | FMS Gravity Tubing |
| 20886705015761 | FMS Fluid Management System Intermediary Tubing Without One-Way valve |
| 10886705016327 | fms Obturator for Cannulas 281572 |
| 10886705023769 | FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow-Linvatec |
| 10886705023752 | FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Wolf |
| 10886705023745 | FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Stryker |
| 10886705023738 | FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Storz |
| 10886705023721 | FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Smith & Nephew |
| 10886705023714 | FMS INFLOW/OUTFLOW SHEATH KIT Inflow/Outflow Sheath-Olympus |
| 10886705023660 | FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Wolf |
| 10886705023653 | FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Stryker |
| 10886705023646 | FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Storz |
| 10886705023639 | FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Smith & Nephew |
| 10886705023622 | FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Olympus |
| 10886705023615 | FMS INFLOW/OUTFLOW SHEATH Obturator Inflow/Outflow-Linvatec |
| 10886705018369 | FMS Remote Control For FMS SOLO |
| 10886705017256 | FMS 4 Way Foot Pedal For FMS DUO Plus |
| 10886705017249 | FMS 2 Way Foot Pedal for FMS DUO PLUS |
| 10886705017232 | FMS 1 Way Foot Pedal for FMS SOLO |
| 10886705016341 | fms Trocar for Cannulas 281580 |
| 10886705016440 | FMS Hand Control Interface To Arthrex Adapteur Power System II |
| 20886705016331 | FMS Fluid Management System 4.5mm FMS Outflow Cannula |
| 20886705016317 | FMS Fluid Management System 2.5mm FMS Outflow Cannula |
| 10886705020478 | FMS Fluid Management System FMS CONNECT Interface Cable - DUO PLUS/SOLO |
| 20886705025494 | FMS Round Tornado Burr Plus 5.0mm |
| 20886705025449 | FMS Round Burr Plus 5.0mm |
| 20886705025432 | FMS Round Tornado Burr Plus 4.0mm |
| 20886705025425 | FMS Round Burr Plus 4.0mm |
| 20886705025111 | FMS XL ROUND TORNADO BURR PLUS 5.0mm |
| 20886705025104 | FMS XL ROUND BURR PLUS 5.0mm |
| 20886705025098 | FMS XL ROUND TORNADO BURR PLUS 4.0mm |
| 20886705025081 | FMS XL ROUND BURR PLUS 4.0mm |
| 20886705025067 | FMS XL ULTRA-AGGRESSIVE RADIUS BLADE PLUS 4.2mm |
| 20886705025050 | FMS XL AGGRESSIVE BLADE PLUS 4.2mm |
| 20886705025043 | FMS XL FULL RADIUS BLADE PLUS 4.2mm |
| 20886705025036 | FMS XL MULTI BLADE PLUS 4.2mm |
| 20886705023094 | FMS BARREL BURR PLUS 5.0mm FOR USE with FMS DUO+ System |
| 20886705023087 | FMS BARREL BURR PLUS 5.0mm |
| 20886705022226 | FMS ULTRA-AGGRESSIVE BLADE PLUS 4.0mm |
| 20886705022103 | FMS BARREL TORNADO BURR PLUS 5.0mm |
| 20886705022097 | FMS MULTI BLADE PLUS 5.0mm |
| 20886705022080 | FMS ULTRA-AGGRESSIVE BLADE PLUS 5.0mm |