| Primary Device ID | 00810111540971 |
| NIH Device Record Key | d540a982-2518-4a84-959b-62f5079f13d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uni-Etch w/BAC |
| Version Model Number | E-5502EBM |
| Catalog Number | E-5502EBM |
| 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 | true |
| 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 |
| 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 | 00810111540971 [Primary] |
| HIBCC | D757E5502EBM1 [Previous] |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-10 |
| Device Publish Date | 2022-08-02 |
| D757E56620 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30ml Syringe |
| D757E5622EB0 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 5g Syr |
| D757E5502EBM1 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 4-Syr Pkg |
| 00810111540971 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 4-Syr Pkg |
| 00810111540964 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 5g Syr |
| 10810111540992 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30ml Syringe |
| 00810111540988 | Uni-Etch w/BAC (32% Phosphoric Acid Etchant w/BAC) 30gm Btl Pkg |