| Primary Device ID | 10886705006564 |
| NIH Device Record Key | 64e2dc12-b7e0-49f5-af6a-a5e7273c671f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRACKER |
| Version Model Number | 219454 |
| Catalog Number | 219454 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705006564 [Primary] |
| NBH | ACCESSORIES,ARTHROSCOPIC |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
[10886705006564]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-08-30 |
| Device Publish Date | 2015-09-01 |
| 10886705006564 | TRACKER RETRACTOR |
| 10886705006663 | TRACKER ANCHOR PIN 2.0mm x 77mm |
| 10886705006656 | TRACKER ANCHOR PIN 2.0mm x 64mm |
| 10886705006649 | TRACKER ANCHOR PIN 2.0mm x 45mm |
| 10886705006632 | TRACKER DRILL BIT 4.5mm x 16.5cm |
| 10886705006625 | TRACKER DRILL BIT 3.2mm x 17.8cm |
| 10886705006618 | TRACKER DRILL BIT 2.0mm x 16.5cm |
| 10886705006601 | TRACKER POSITIONING CARD |
| 10886705006595 | TRACKER BONE CLAMP |
| 10886705006588 | TRACKER ANCHOR PIN PULLER |
| 10886705006571 | TRACKER SLOPE SELECTOR ARM |
| 10886705004607 | TRACKER MODULE |