| Primary Device ID | 00810092939788 |
| NIH Device Record Key | baed21eb-ab3a-4b7b-87a3-13f18e099110 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excalibur sterile 21mm E45 |
| Version Model Number | ZRE2104505 |
| Company DUNS | 185497372 |
| Company Name | NUSMILE, LTD. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com | |
| Phone | 832-540-5964 |
| plara@nusmile.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810092939788 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-25 |
| Device Publish Date | 2022-08-17 |
| 00810092939788 | Blister of 6 units |
| 00810092939818 | Blister of 6 units |