| Primary Device ID | 00303620000864 |
| NIH Device Record Key | 121ff089-adb9-4df9-8041-5d511c92a852 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEPTODONT IMAGE MH L/C REFILL SYRINGE A1 |
| Version Model Number | 01C2081 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (303) 665-7535 |
| usregulatoryaffairs@septodont.com |
| Weight | 4.5 Gram |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00303620000864 [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 |
| 13760140703608 - R.T.R Membrane | 2021-02-08 Absorbable Collagen Membrane (15X20MM) for dental surgery. |
| 03760140703618 - R.T.R Membrane | 2021-02-08 Absorbable Collagen Membrane (20X30MM) for dental surgery |
| 13760140703622 - R.T.R Membrane | 2021-02-08 Absorbable Collagen Membrane (30X40MM) for dental surgery. |
| 00303620000291 - EARLOOP FACE MASK BLUE 3 PLY (2115) | 2020-05-06 FACEMASK BLUE E/L |
| 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) |