| Primary Device ID | 10886705006205 |
| NIH Device Record Key | c25d1737-a22e-47e1-9132-171a11bc992d |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 219391 |
| Catalog Number | 219391 |
| 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 | |
| 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 | 10886705006205 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
[10886705006205]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-09-18 |
| Device Publish Date | 2015-09-01 |
| 20886705011022 - STRAIGHTSHOT | 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm |
| 20886705011039 - STRAIGHTSHOT | 2024-08-20 STRAIGHTSHOT LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm |
| 20886705011060 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 7.5mm |
| 20886705011077 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 8.5mm |
| 20886705011084 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 9.5mm |
| 20886705011091 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 10.5mm |
| 20886705011107 - NA | 2024-08-20 LIGAMENT GRAFT PASSER/PROTECTOR 11.5mm |
| 10886705012480 - COR | 2024-08-20 Mitek COR Plunger 4mm, 5-25mm (Plus or Minus 10 Percent) |