| Primary Device ID | D801ID60051I1 |
| NIH Device Record Key | da2c67ee-7b34-401b-8efc-34ec86a10d8e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | International Dental Supply Eclipse Visible Light-Cured Orthodontic Adhesive |
| Version Model Number | ID 60-051 I |
| Catalog Number | 60-05 |
| Company DUNS | 096010525 |
| Company Name | SCIENTIFIC PHARMACEUTICALS, 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 | true |
| 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 | 800-634-3047 |
| Denise@scipharm.com | |
| Phone | 800-634-3047 |
| Denise@scipharm.com |
| Storage Environment Temperature | Between 0 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D801ID60051I1 [Primary] |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-11 |
| D801ID6005I1 | CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Kit. Italian |
| D801ID60052I1 | CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Enamel Primer Bottle. Boxed. Italian. |
| D801ID60051I1 | CuRay Eclipse Visible Light-Cured Orthodontic Adhesive Syringe. Italian. |