| Primary Device ID | 00303620000529 |
| NIH Device Record Key | f979476d-f02b-4f7b-9466-666dd7bf15b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEPTODONT ADHERENCE SC 2-9GM DBL BAR SYR |
| Version Model Number | 01C2003 |
| Catalog Number | 01C2003 |
| 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 | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (303) 665-7535 |
| usregulatoryaffairs@septodont.com |
| Weight | 9 Gram |
| Storage Environment Temperature | Between 15 Degrees Celsius and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00303620000529 [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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| 00303620000307 - EARLOOP FACE MASK PINK 3 PLY (2116) | 2020-05-06 FACEMASK PINK E/L |
| 00303620000314 - EARLOOP FACE MASK WHITE 3 PLY (2130) | 2020-05-06 MASK E/L WH L1 |
| 00303620000109 - 2 INCH CLEAR CONT NYL FILM (0002) | 2019-11-08 2 INCH CLEAR CONT NYL FILM (0002) |
| 00303620000116 - 3 INCH CLEAR CONT NYLON FILM (0003) | 2019-11-08 3 INCH CLEAR CONT NYLON FILM (0003) |