| Primary Device ID | 10889950140984 | 
| NIH Device Record Key | d32f0c70-c395-4c45-b110-4721b68f3a5b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | HuFriedyGroup | 
| Version Model Number | PMEKIT | 
| Company DUNS | 005085972 | 
| Company Name | HU-FRIEDY MFG. CO., 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 | false | 
| Serial Number | false | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | |
| Phone | +1(800)483-7433 | 
| info@hu-friedy.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10889950140984 [Primary] | 
| FSM | TRAY, SURGICAL, INSTRUMENT | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-07-19 | 
| Device Publish Date | 2023-07-11 | 
| 10889950140748 | HVE Mirror Connect, Sample | 
| 00889950140710 | HVE Mirror Connect, Bulk | 
| 10889950076139 | Spore Check, Incubator | 
| 10889950140991 | Pink Matters Essential Kit, DIN | 
| 10889950140984 | Pink Matters Essential Kit | 
| 10889950143916 | Loaner- PWR Air Perio Handpiece | 
| 10889950143893 | DEMO- PWR Air Perio Handpiece | 
| 10889950143879 | Loaner- PWR Air 120° Handpiece | 
| 10889950143855 | DEMO- PWR Air 120° Handpiece | 
| 10889950143831 | Loaner- PWR Piezo LED Handpiece | 
| 10889950143817 | DEMO- PWR Piezo LED Handpiece | 
| 10889950143602 | Loaner-PWR Piezo Unit | 
| 10889950143589 | Loaner-PWR Pair Combo Unit | 
| 10889950143565 | DEMO-PWR Piezo Unit | 
| 10889950143541 | DEMO-PWR Pair Combo Unit |