| Primary Device ID | 10810111541715 |
| NIH Device Record Key | 8c531b3d-2fd6-44c3-b5bd-8041ba758526 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aelite All-Purpose Body |
| Version Model Number | H-812A2 |
| Catalog Number | H-812A2 |
| Company DUNS | 053529939 |
| Company Name | BISCO 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 | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com | |
| Phone | +1(847)534-6000 |
| sales@bisco.com |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 20 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810111541718 [Primary] |
| GS1 | 10810111541715 [Package] Contains: 00810111541718 Package: Item No: H-812A2P [1 Units] In Commercial Distribution |
| HIBCC | D757H812A20 [Previous] |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-18 |
| Device Publish Date | 2022-10-10 |
| D757H814B1P1 | Aelite All-Purpose Body B1 15ct Unit Dose (0.25g ea) Pkg |
| D757H814B10 | Aelite All-Purpose Body B1 15ct Unit Dose (0.25g ea) |
| D757H814A3P1 | Aelite All-Purpose Body A3 15ct Unit Dose (0.25g ea) Pkg |
| D757H814A35P1 | Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea) Pkg |
| D757H814A350 | Aelite All-Purpose Body A3.5 15ct Unit Dose (0.25g ea) |
| D757H814A30 | Aelite All-Purpose Body A3 15ct Unit Dose (0.25g ea) |
| D757H814A2P1 | Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea) Pkg |
| D757H814A20 | Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea) |
| D757H814A1P1 | Aelite All-Purpose Body A1 15ct Unit Dose (0.25g ea) Pkg |
| D757H814A10 | Aelite All-Purpose Body A1 15ct Unit Dose (0.25g ea) |
| D757H812B1P1 | Aelite All-Purpose Body B1 4g Syringe Pkg |
| D757H812B10 | Aelite All-Purpose Body B1 4g Syringe |
| D757H812A3P1 | Aelite All-Purpose Body A3 4g Syringe Pkg |
| D757H812A35P1 | Aelite All-Purpose Body A3.5 4g Syringe Pkg |
| D757H812A350 | Aelite All-Purpose Body A3.5 4g Syringe |
| D757H812A30 | Aelite All-Purpose Body A3 4g Syringe |
| D757H812A2P1 | Aelite All-Purpose Body A2 4g Syringe Pkg |
| D757H812A20 | Aelite All-Purpose Body A2 4g Syringe |
| D757H812A1P1 | Aelite All-Purpose Body A1 4g Syringe Pkg |
| D757H812A10 | Aelite All-Purpose Body A1 4g Syringe |
| 10810111541746 | Aelite All-Purpose Body B1 4g Syringe |
| 10810111541722 | Aelite All-Purpose Body A3 4g Syringe |
| 10810111541715 | Aelite All-Purpose Body A2 4g Syringe |
| 10810111541708 | Aelite All-Purpose Body A1 4g Syringe |
| 20810111541767 | Aelite All-Purpose Body A2 15ct Unit Dose (0.25g ea) |