| Primary Device ID | 07540187001108 |
| NIH Device Record Key | d0b9dd7c-d449-4581-9b4e-38536157c8aa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Novocol GRANITEC ORTHODONTIC FLOWABLE COMPO 1-2G |
| Version Model Number | FP-NOVOINC-058 |
| Company DUNS | 012925513 |
| Company Name | SEPTODONT, INC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540187001108 [Primary] |
| EBF | Material, Tooth Shade, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-12 |
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| 00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003) | 2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003) |