| Primary Device ID | 04582276040127 | 
| NIH Device Record Key | 7ed150e0-3755-4f1a-adb7-87882f6534c2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | NAPERCE | 
| Version Model Number | M34L, W0.5 | 
| Company DUNS | 693430001 | 
| Company Name | YAMAHACHI DENTAL MFG.,CO. | 
| 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 | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false |