| Primary Device ID | EBIB039101 |
| NIH Device Record Key | eebd1122-144e-4ed5-aae3-8a6e4a63a500 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plicafol |
| Version Model Number | 03910 |
| Catalog Number | 03910 |
| Company DUNS | 316133664 |
| Company Name | bisico Bielefelder Dentalsilicone GmbH & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 | +495218016800 |
| info@bisico.de |
| Handling Environment Temperature | Between 7 Degrees Celsius and 32 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EBIB039101 [Primary] |
| EGD | Wax, Dental, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-06-29 |
| Device Publish Date | 2020-06-05 |
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