| Primary Device ID | J014660799270 |
| NIH Device Record Key | c1d1f680-ed1c-427b-82c6-04e4e28c4787 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Signum universal bond |
| Version Model Number | 66079927 |
| Catalog Number | 66079927 |
| Company DUNS | 315666321 |
| Company Name | Kulzer GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx | |
| Phone | +1(800)431-1785 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J014660799270 [Primary] |
| 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 | 2024-11-29 |
| Device Publish Date | 2024-11-21 |
| J014660799270 | Signum universal bond II, 4 ml |
| J014660799260 | Signum universal bond I, 4 ml |
| J014660799230 | Signum universal bond (set) |