| Primary Device ID | 20815634020003 |
| NIH Device Record Key | 9ab53a69-a233-467a-ac1a-1aaf6d83abd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MITEK SPORTS MEDICINE |
| Version Model Number | 278011 |
| Company DUNS | 066839630 |
| Company Name | MICROMEDICS, 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815634020009 [Primary] |
| GS1 | 10815634020006 [Package] Contains: 00815634020009 Package: Inner Pack [10 Units] In Commercial Distribution |
| GS1 | 20815634020003 [Package] Contains: 10815634020006 Package: Case [5 Units] In Commercial Distribution |
| KYZ | Syringe, Irrigating (Non Dental) |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
[20815634020003]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-18 |
| Device Publish Date | 2019-01-16 |
| 20815634020041 | MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 18 CM |
| 20815634020034 | MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 10 CM |
| 00815634020023 | MITEK SPORTS MEDICINE DUAL CANNULA, MALLEABLE APPLICATOR TIP 20 GA X 5 CM |
| 20815634020010 | MITEK SPORTS MEDICINE DUAL SPRAY TIP APPLICATOR TIP |
| 20815634020003 | MITEK SPORTS MEDICINE RATIO APPLICATOR ASSEMBLY 11:1 |